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Clinical Trials – WTZ Essen (Westdeutsches Tumorzentrum Essen ...

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<strong>Clinical</strong> <strong>Trials</strong> – <strong>WTZ</strong> <strong>Essen</strong> (<strong>Westdeutsches</strong> <strong>Tumorzentrum</strong> <strong>Essen</strong>)<br />

Title of Project Indication / Site Phase Sponsor / Funding<br />

Organization<br />

Investigator Initiated<br />

Trial<br />

Prospective randomized Phase III trial of standard<br />

definitive boost radiotherapy versus surgery following<br />

induction chemotherapy with cisplatin/paclitaxel and<br />

neoadjuvant chemoradiotherapy based on<br />

hyperfractionated radiotherapy (ESPATü)<br />

Lung Cancer<br />

Lung cancer III Universitätsklinikum<br />

<strong>Essen</strong><br />

Eberhardt, Wilfried,<br />

Dr. med.<br />

(IIT)<br />

A diagnostic companion study to detect circulating tumor<br />

cells (CTC) harboring somatic epidermal growth factor<br />

receptor (EGFR) gene mutations in patients with nonsmall<br />

cell lung cancer (NSCLC) treated with gefitinib,<br />

erlotinib, cisplatin/pemetrexed or BIBW2992<br />

EGFR mutant lung<br />

cancer<br />

Pilot<br />

Universitätsklinikum<br />

<strong>Essen</strong><br />

Prof. Dr. med. Martin<br />

Schuler<br />

(IIT)<br />

Sorafenib in Resected NSCLC (SIRN) - A Phase II Study<br />

to Investigate the Efficacy and Safety of Sorafenib as<br />

Adjuvant Treatment following Resection of Non-small<br />

Cell Lung Carcinoma (NSCLC) in Patients not eligible for<br />

Cisplatin-based Adjuvant Chemotherapy<br />

Thorax II Johannes Gutenberg<br />

Universität Mainz<br />

Prof. Dr. med. Martin<br />

Schuler<br />

(IIT)<br />

BI1200.32: Randomized phase III trial of BIBW2992<br />

versus Cisplatin/Pemetrexed in first-line therapie<br />

advanced NSCLC haboring EGFR mutations<br />

BI1200.42: Randomized phase III trial of BIBW2992 in<br />

combination with paclitaxel versus investigators choice in<br />

patients with advanced NSCLC relapsing after erlotinib or<br />

gefitinib<br />

NSCLC III Boehringer Ingelheim Prof. Dr. med. Martin<br />

Schuler – Glonal<br />

NSCLC III Boehringer Ingelheim Prof. Dr. med. Martin<br />

Schuler – Global<br />

Coordinating Investigator<br />

GSK MAGRIT MAGE3-AS15-NSC-003 NSCLC III GlaxoSmithKline no<br />

RADIANT OSI 774-302 NSCLC III OSI no<br />

Novartis CRAD001C2114 NSCLC I Novartis no<br />

SAIL Roche 19390 NSCLC Roche no<br />

Pfizer A6181087 Erlotinib bs. Erlotinib+SUN NSCLC III Pfizer no


AURORA Nerviano AURA-6202-006<br />

BERLINStudie Carboplatin + Irinotecan vs Carboplatin +<br />

Etoposid<br />

Breast, small cell lung<br />

and non small cell lung<br />

cancers. (closed for<br />

pancreatic, ovarial and<br />

colorectal cancers)<br />

II Nerviano no<br />

SCLC III AIO no<br />

Bayer 310101 Epothilon-Studie SCLC I / II Schering no<br />

START EMR 63325-001 NSCLC III Merck no<br />

TIE ML19747 NSCLC II AIO/Roche no<br />

TREAT / AIO NSCLC II AIO/Lilly no<br />

Sanofi Aventis VEGF-Trap VITAL NSCLC II Sanofi Aventis no<br />

Astra Zeneca REASON NSCLC n/a Astra Zeneca no<br />

Novartis ATTRACT2 NSCLC III Novartis no<br />

Pfizer A8081005 NSCLC II Pfizer no<br />

Pfizer A8081007 NSCLC III Pfizer no<br />

Roche Humab NO21160 NSCLC Roche no<br />

Bayer ESCAPE 11961 NSCLC III Bayer no<br />

Merck EMD72000-031 NSCLC II Merck no<br />

Pfizer A8501001 NSCLC III Pfizer no<br />

Bayer PTK NSCLC II Bayer no<br />

Astra Zeneca D4200C00032 NSCLC III Astra Zeneca no<br />

Novartis Zometa CZOL446G2419 NSCLC III Novartis no<br />

Bayer 12006 NEXUS NSCLC III Bayer no<br />

Astra Zeneca EPICLIN NSCLC n/a Astra Zeneca no<br />

Celgene AMR PH GL 2007 CL 001 SCLC III Celgene no


Novartis ATTRACT1 NSCLC III Novartis no<br />

BI1200.23 NSCLC IIb/III Boehringer Ingelheim no<br />

Stem Cell Transplantation<br />

Autologous or allogeneic transplantation following<br />

conventional chemotherapy in younger Patients (18-60<br />

yrs) with mature ALK negative peripheral T-cell<br />

lymphoma (DSHNHL 2006-1A)<br />

Aggressive<br />

T-cell lymhoma<br />

Phase III <strong>Clinical</strong> Trial Center HH Prof.Dr. N. Schmitz<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

AML- SCT<br />

Allogenic stem cell<br />

transplantation acute<br />

myeloic leucemia<br />

N / A<br />

Hannover clinical Trial<br />

Center<br />

PD Dr. med. Martin Sauer<br />

<strong>Clinical</strong> Phase III trial to compare Treosulfan-based<br />

conditioning therapy with Busulfan-based reducedintensity<br />

conditioning (RIC) prior to allogeneic stem cell<br />

transplantation in patients with AML or MDS considered<br />

ineligible to standard conditioning regimens (MC-<br />

FludT.14/L)]<br />

Acute myeloid leukemia<br />

Myelodysplastic<br />

syndromes<br />

Phase III MEDAC GmbH Prof. Dr. D. W. Beelen<br />

(coordinating investigator)<br />

Phase II study Allogeneic Stem Cell Transplantation with<br />

Treosulfan, VP-16 and Cyclophosphamide for patients<br />

with Acute Lymphoblastic Leukemia (ALL) not eligible for<br />

TBI-containing regimens (Allo-SCT -- Treo-VP16-Cyclo /<br />

ALL)<br />

Acute lymphoblastic<br />

leukemia<br />

Phase II<br />

CTS<br />

(<strong>Clinical</strong> Trial Solutions)<br />

MEDAC GmbH<br />

Prof. Dr. D. W. Beelen,<br />

<strong>Essen</strong><br />

Prof. Dr. N. Kröger ,<br />

Hamburg<br />

(coordinating investigators)<br />

AML: Phase II study of haploidentical hematopoietic cell<br />

transplantation with CD3/CD19 depleted grafts after a<br />

reduced intensity conditioning regimen (E 410/2007)<br />

Acute myeloid leukemia Phase II University Hospital<br />

Tübingen<br />

PD Dr. W. Bethge,Tübingen<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Lenalidomide maintenance therapy in patients with MDS<br />

or AML with cytogenetic abnormalities involving<br />

monosomy 5 or del5q after allogeneic hematopoietic<br />

stem cell transplantation - LENAMAINT<br />

Acute myeloid leukemia<br />

Myelodysplastic<br />

syndromes<br />

Phase I/II ClinAssess Leverkusen PD Dr. U. Platzbecker,<br />

Dresden<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen


Multicenter randomized study comparing oral<br />

valganciclovir versus intravenous ganciclovir in patients<br />

following allogeneic stem cell transplantation (ML 22371)<br />

Cytomegalovirus<br />

infection<br />

Phase III IFE Europe GmbH Prof. Dr. H. Einsele,<br />

Würzburg<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Evaluation of allogeneic cell transplantation in acute<br />

myeloid leukemia I (ETAL I)<br />

Acute myeloid leukemia Phase III DFG Prof. Dr. M. Bornhäuser,<br />

Dresden<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Prospektive offene multizentrische Phase II-Studie zur<br />

Effektivität von Palifermin (Kepivance) in der Prophylaxe<br />

der Mukositis nach allogener Stamzelltransplantation mit<br />

myeloablativer Ganzkörperbestrahlung (OSHO 76)<br />

Phase-III study on the value of allogeneic stem cell transplantation<br />

in poor-risk chronic lymphocytic leukemia<br />

(GCLLSG/GCTSG CLL-X2 trial)<br />

Akute und chronische<br />

Leukämien<br />

Chronic lymphocytic<br />

leukemia<br />

Phase III WISP GmbH PD. Dr. H. Sayer, Jena<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Phase III DFG Prof. Dr. P. Dreger,<br />

Heidelberg<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Autologous-allogeneic tandem stem cell transplantation<br />

and maintenance therapy with Thalidomide/DLI for<br />

patients with multiple myeloma and age ≤ 60 years: a<br />

phase II-study<br />

Muliple myeloma Phase II University Medical Center<br />

Hamburg-Eppendorf<br />

Prof. Dr. N. Kröger,<br />

Hamburg<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Double-blind, placebo-controlled, randomized multicenter<br />

phase III trial to access the efficacy of Sorafenibmaintenance<br />

therapy in Flt3-ITD positive AML in<br />

complete remission<br />

Acute myeloid leukemia Phase II KKS Marburg Prof Dr. A. Neubauer<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen


A randomized, multicenter phase III-study to compare the<br />

efficacy and safety of early pre-emptive versus minimal<br />

residual disease (MRD)-triggered administration of<br />

Imatinib Mesylate (STI571, Glivec) after stem cell<br />

transplantation for Ph+/BCR-ABL+ acute lymphoblastic<br />

leukemia (Ph+ALL).<br />

Acute lymphoblastic<br />

leukemia<br />

Phase III Univ. Frankfurt Prof. Dr. O.G. Ottmann,<br />

Frankfurt<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

A randomized, risk and age adapted comparison of the<br />

dose-dense regimen S-HAM (sequential high-dose<br />

cytosine arabinoside and mitoxantrone) versus standard<br />

double induction for initial chemotherapy of adult patients<br />

with acute myeloid leukemia<br />

Acute myeloid leukemia Phase III DKH Prof. Dr. W. Hiddemann,<br />

München<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Multizentrische Therapieoptimierungsstudie der akuten<br />

lymphatischen Leukaemie bei Erwachsenen und<br />

Adoleszenten ab 18 Jahren (GMALL 07/2003) -<br />

Therapieoptimierung durch Evaluation der minimalen<br />

Resterkrankung -<br />

Randomisierter kontrollierter Vergleich von Imatinib vs.<br />

Imatinib und Interferon-alpha vs. Imatinib 800 mg mit<br />

Prüfung des Stellenwertes der allogenen<br />

Stammzelltransplantation bei neu diagnostizierter CML in<br />

chronischer Phase<br />

Acute lymphoblastic<br />

leukemia<br />

Chronische myeloische<br />

Leukämie<br />

Phase III DKH Prof. Dr. D. Hoelzer,<br />

Frankfurt<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Phase IV DKH Prof. Dr. R. Hehlmann,<br />

Mannheim<br />

(coordinating investigator)<br />

PI <strong>Essen</strong>:<br />

Prof. Dr. D. W. Beelen<br />

Prospective multicentre validation of National Insitutes of<br />

Health criteria of chronic graft-versus-host –disease in<br />

children and adolescents following allogenic stem cell<br />

transplation<br />

cGvHD-Project N / A St. Anna-Kinderspital,<br />

Wien<br />

Melanoma<br />

Dr. med. Lawitschka<br />

Klinische Phase-III Studie der ADO "Individualisierte<br />

Therapie nach Chemosensitivitätsprofil versus DTIC<br />

beim metastasierten Melanom"<br />

Metastasiertes<br />

Melanom Stadium IIIC<br />

nicht resezierbar und<br />

Stadium IV<br />

III ADO Prof. Dr. Selma Ugurel,<br />

Uniklinikum Würzburg<br />

Arbeitsgemeinschaft<br />

Dermatologische Onkologie<br />

(ADO)


Adjuvant immunotherapie with anti-CTLA-4 monoclonal<br />

antibody (ipilimumab) versus placebo after complete<br />

resection of high-risk Stage III melanoma: A<br />

Randomized, double-blind Phase 3 trial of the EORTC<br />

Melanoma Group (BMS CA184 029)<br />

A double blind, randomized, placebo controlled Phase III<br />

Study to assess the efficacy of recMAGE-A3+AS15 ASCI<br />

as adjuvant therapy in Patients with MAGE-A3 positive<br />

resected stage III melanoma<br />

An open, single-arm trial to assess the clinical activity of<br />

recMAGE-A3 + AS15 in Patients with unresectable<br />

MAGE-A3-positive, metastasic cutaneous melanoma<br />

ADO-CTCL-3 (TARADO): Multizentrisches Therapie-<br />

Protokoll zur Bexaroten (Targretin®)-Monotherapie bei<br />

vorbehandeltem CTCL Stadium ≥Ib mit klarer Zuordnung<br />

einer EORTC-Diagnose<br />

PRAME-AS15-MEL-001 (met) An open , dose-escalation<br />

Phase I/II study to assess the safety, immunogeneticity<br />

and clinical activity of recPRAME + AS15 Antigen-<br />

Specific Cancer Immunotherapeutic as first-line<br />

treatment of patients with PRAME-positive metastati<br />

Protocol H8K-MC-JZAO A Randomized Phase 3 Study of<br />

Tasisulam Administered as an Intravenous Infusion on<br />

Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line<br />

Treatment in Patients with Metastatic Melanoma<br />

Malignes Melanom<br />

Stadium III komplett<br />

resezierbar<br />

MAGE-A3-positives<br />

Melanom Stadium III<br />

MAGE-A3-positives<br />

nicht resezierbares<br />

Melanom Stadium III<br />

oder IV M1a<br />

Mycosis fungoides,<br />

Sezary-Syndrome, 10-<br />

30 CD30-positive CTCL,<br />

lymphomatoide<br />

Papulosen, NK-<br />

Lymphome<br />

Phase I: Stadium IV,<br />

M1b und M1c und<br />

Patienten mit vollständig<br />

reseziertem Tumor im<br />

Stadium IV Phase II:<br />

Stadium III, messbar<br />

und nicht resezierbar,<br />

einschließlich in-transit<br />

Metastasen und<br />

Patienten im Stadium<br />

M1a<br />

Malignes Melanonom im<br />

Stadium IV<br />

III<br />

Bristol-Myers-Squibb/<br />

EORTC<br />

no<br />

III Glaxo Smith Kline no<br />

III Glaxo Smith Kline no<br />

/ Cephalon Prof. Dr. Reinhard Dummer,<br />

Universitätsspital Zürich,<br />

Arbeitsgemeinschaft<br />

Dermatologische<br />

Onkologie(ADO)<br />

I / II Glaxo Smith Kline no<br />

III Eli - Lilly no


The TEAM Trial (Tasigna Efficacy in advanced<br />

Melanoma): A randimized, phase III, open-label, multicenter,<br />

two-arm study to compare the efficacy of Tasigna<br />

® versus dacarbazine (DTIC) in treatment of Patients<br />

with inoperable metastatic acral, mucosal or c<br />

A Randomized, open label, controlled, multicenter,<br />

Phase III Study in previously untreated Patient with<br />

unresectable Stage IIIc or Stage IV Melanoma with<br />

V600-Positive BRAF mutation Receiving RO5185426 or<br />

Dacarbazine<br />

SIMPS: An international, prospective, blinded clinical<br />

study designated to determine the safety and<br />

effetiveness of the SciBase III device designed to<br />

distinguish between malignant melanoma and benign<br />

lesions using electrical impedance spectroscopy<br />

A randomized, double-blind, vehicle-controlled,<br />

multicenter<br />

trial of topically administered LDE225 cream (0.75% bid)<br />

to<br />

evaluate clearance of Basal Cell Carcinoma in adult<br />

patients with Nevoid Basal Cell Carcinoma Syndrome<br />

Randomisierte Phase III Studie zum Vergleich von<br />

intravenous versus intraarteriell verabreichtem<br />

Fotemustin bei Patienten mit Lebermetastasen eines<br />

Aderhautmelanoms<br />

NOA-05 phase II trial of procarbazine and lomustine<br />

chemotherapy (PC) in newly diagnosed gliomatosis<br />

cerebri<br />

Therapie für c-Kit-<br />

Mutation positive<br />

Patienten des Exon 11<br />

oder 13, sowie c-Kit<br />

Mutation Y822D /<br />

Y823D des Exon 17 bei<br />

einem metastasierten<br />

Schleimhautmelanom,<br />

akralen- oder kutanen<br />

Melanom<br />

Für BRAF-positive<br />

Patienten mit Malignem<br />

Melanom im nicht<br />

resezierbaren Stadium<br />

IIIC oder Stadium IV<br />

Patienten mit Verdacht<br />

auf maligne Läsion<br />

BCC Gorlin Golz<br />

Syndrom<br />

III Novartis no<br />

III Roche no<br />

MPG SciBase AB no<br />

III Novartis no<br />

Uvealmelanoma III EORTC no<br />

Neuroectodermal Tumors<br />

Gliomatosis cerebri /<br />

Brain<br />

Multicentric<br />

phase II study<br />

N/A<br />

Prof. Dr. U. Herrlinger,<br />

Bonn


HIT- HGG<br />

HIT-REZ<br />

HIT-HGG - CilMetro<br />

High Grade<br />

Glioblastoma<br />

High Grade Gliomas<br />

and Refracotry /<br />

Relapse PNET and<br />

Medulloblastoma<br />

refractory High Grade<br />

Gliomas<br />

Phase II UK Halle / S. PD Dr. med. Kramm<br />

Phase II UK Bonn Prof. Dr. med. Fleischhack<br />

Phase II UK Halle / S PD Dr. med. Kramm<br />

HIT-REZ.<br />

intrathecal therapy with<br />

liposomal cytarabine<br />

( DepoCyte)<br />

Phase II<br />

Mundipharma Research<br />

UK Bonn<br />

Prof. Dr. med. Fleischhack<br />

DIRECTOR – Dose intensified rechallenge with<br />

temozolomide, one week on one week off versus three<br />

weeks on one week off in patients with progressive or<br />

recurrent glioblastoma<br />

Glioblastoma / Brain<br />

Multicentric<br />

phase II study<br />

Schering-Plough<br />

Prof. Dr. M. Weller, Zurich<br />

NOA-08 randomized phase III trial of 1 week on/1 week<br />

off temozolomide versus involved-field radiotherapy in<br />

elderly (older than age 65) patients with newly diagnosed<br />

anaplastic astrocytoma or glioblastoma (Methusalem)<br />

Glioblastoma / Brain<br />

Multicentric<br />

phase III study<br />

Essex Pharma / Schering-<br />

Plough<br />

Prof. Dr. W. Wick,<br />

Heidelberg<br />

AWB P04739 study on concomitant and adjuvant<br />

temozolomide and radiotherapy for the treatment of<br />

glioblastoma<br />

Glioblastoma / Brain<br />

Multicentric<br />

post marketing<br />

survaillance<br />

study<br />

N/A<br />

Prof. Dr. W. Stummer,<br />

Heidelberg<br />

Whole Brain radiotherapy (WBRT) vs.WBRT and<br />

integrated boost using helical tomotherapy for patients<br />

with multiple brain metastases – a multicentre<br />

randomized phase II trial<br />

Brain metastases<br />

Randomized<br />

Phase II<br />

Stuschke<br />

Other<br />

Ariad AP23573-07-302 STS II ARIAD no<br />

EORTC 62931 STS III EORTC no


EORTC 62961 STS III EORTC no<br />

EORTC 62072 STS III EORTC no<br />

Sabine STS Surveillance Merck & Co no<br />

AP23573-07-302 A pivotal trial to determine the efficacy<br />

and safety of AP23573 when administered as<br />

maintenance therapiy to patients with metastastic softtissue<br />

or bone sarcomas<br />

EORTC 62061: Randomized phase II study of brostallicin<br />

(PNU-166196A) versus doxorubicin as first line<br />

chemotherapy in patients with advanced or metastatic<br />

soft tissue sarcoma<br />

EORTC 62072: A randomized double blind phase IIIof<br />

Pazopanib versus placebo in patients with soft tissue<br />

sarcoma whose disease has progressed during or<br />

following prior therapy<br />

STS II ARIAD no<br />

STS III EORTC no<br />

STS III EORTC no<br />

CARIN<br />

WX/60-006<br />

CRAD001W2301 (Bolero-3)<br />

L00070 IN 308 B0 (Vinflunin vs Alkylanz)<br />

Treatment reality and survival (tumor registry)<br />

Metastatic breast<br />

cancer<br />

Metastatic breast<br />

cancer<br />

Metastatic breast<br />

cancer<br />

Metastatic breast<br />

cancer<br />

Metastatic breast<br />

cancer<br />

II, randomis. Iomedico no<br />

III Wilex AG no<br />

III Novartis no<br />

III Pierre Fabre no<br />

N/A IOmedico no<br />

Phase I study of imatinib and LBH589 in imatinib- and<br />

sunitinib-refractory gastrointestinal stromal tumors<br />

GIST I Universitätsklinikum<br />

<strong>Essen</strong><br />

PD Dr. Sebastian Bauer<br />

(IIT)<br />

An open-label, multi-center study to evaluate the efficacy<br />

of nilotinib in adult patients with gastrointestinal stromal<br />

tumors resistant to imatinib and Sunitinib<br />

(CAMN107DDE05)<br />

GIST II Novartis no


CAMN107G2301 GIST III Novartis no<br />

S.A.K.K.57-07 GIST II S.A.K.K. no<br />

CAMN107G2301 A randomized, open-label, multi-center<br />

phase III study to evaluate the efficacy and safety of<br />

nilotinib versus imatinib in adult patients with<br />

unresectable or metastatic gastrointestinal stromal tumor<br />

GIST)<br />

GIST III Novartis no<br />

CAMN107DDE05 GIST III Novartis no<br />

AMN107A2201: A randomized, open-label, multi-center<br />

study to evaluate the efficacy of nilotinib versus best<br />

supportive care with or without a tyrosine kinase inhibitor<br />

(investigator’s choice) in adult patients with<br />

gastrointestinal stromal tumors resistant to both imatinib<br />

and sunitinib<br />

CRAD001C2454 Everolimus Multicenter, single-arm,<br />

two-stage phase II trial of RAD001 (everolismus) with<br />

Glivec in Glivec-resistant patients with progressive GIST<br />

CAM107A2201 Nilotinib A randomized, open-label,<br />

multi-center study to evaluate the efficacy of nilotinib<br />

versus best supportive care with or without a tyrosine<br />

kinase inhibitor in adult patients with gastrointestinal<br />

stromal tumors resistant to both imatinib and sunitinib.<br />

A Phase 3, Randomized, Double-Blind, Placebo-<br />

Controlled, Multi-Center Study Evaluating the Efficacy<br />

and Safety of IPI-504 in Patients with Metastatic and/or<br />

Unresectable Gastrointestinal Stromal Tumors Following<br />

Failure of at Least Imatinib and Sunitinib<br />

Merck Expand EMR 20048-052<br />

Ganymed GM-IMAB-01<br />

GIST III Novartis no<br />

GIST II Novartis no<br />

GIST III Novartis no<br />

GIST III Infinity no<br />

Advanced Esophago-<br />

Gastric Cancer<br />

Advanced<br />

gastroesophageal<br />

cancer<br />

III Merck no<br />

I Ganymed no<br />

GC-CIF-2005 met. gastric cancer II AIO no


Sunitinib Sutent SU11248 Gastric cancer II AIO no<br />

GC-DOR-2004<br />

Adenocarcinoma,<br />

gastroesophageal<br />

transitional<br />

I / II AIO no<br />

EORTC 62061 Brostallicin WTS III EORTC no<br />

Multizentrische Phase II-Studie mit<br />

Pemetrexed bei Patienten mit vorbehandelten<br />

metastasierten Weichteilsarkomen<br />

Randomisierte Phase II-Studie von Trofosfamid versus<br />

Adriamycin bei älteren Patienten mit unvorbehandeltem<br />

metastasiertem Weichteilsarkom<br />

WTS II AIO Prof. Jörg Hartmann, Kiel<br />

WTS II AIO Prof. Jörg Hartmann, Kiel<br />

GEN205<br />

Merck ADVANTAGE<br />

Lilly H3E-MC-S123 Phase 2 study of pemetrexed in<br />

combination with cisplatin and cetuximab in recurrent of<br />

metastatic squamous cell carcinoma of the head and<br />

neck<br />

Head and Neck<br />

carcinoma<br />

Head and Neck<br />

carcinoma<br />

Head and Neck<br />

carcinoma<br />

II Genmab no<br />

II Merck no<br />

II Lilly no<br />

Lilly H3E-MC-JMHR<br />

Head and Neck<br />

Carcinoma<br />

III Lilly no<br />

CeFCiD<br />

Head and Neck<br />

carcinoma<br />

II<br />

Charite Universitätsklinik<br />

Berlin<br />

Prof. Keilholz Charite Berlin<br />

(IIT)<br />

DCC<br />

Head and Neck<br />

carcinoma<br />

II<br />

Charité Universitätsklinik<br />

Berlin<br />

Dr. Dr. Raguse Charite<br />

Berlin (IIT)<br />

CETAX<br />

Head and Neck<br />

carcinoma<br />

II<br />

Charité Universitätsklinik<br />

Berlin<br />

Prof. Keilholz Charite Berlin<br />

(IIT)<br />

Novartis RECORD2 Renal Cell Carcinoma II Novartis no<br />

GSK COMPARZ Renal Cell Carcinoma III GlaxoSmithKline no


CESAR C-II-006 Renal Cell Carcinoma II CESAR no<br />

Pfizer AXIS A4061032 RCC III Pfizer no<br />

Novartis CRAD001L2401 RCC IIIb Novartis no<br />

Pfizer A6181037 Metastatic RCC II Pfizer no<br />

Prospektive, randomisierte, kontrollierte, unizentrische,<br />

offene, Studie zur Thromboembolieprophylaxe mit<br />

Enoxaparin bei nicht-chirurgischen onkologischen<br />

Patienten unter systemischer antineoplastischer<br />

Therapie<br />

Solide Tumore II Universitätsklinikum<br />

<strong>Essen</strong><br />

Prof. Dr. med. M. E.<br />

Scheulen<br />

(IIT)<br />

Astra Zeneca 14-er Solid tumors I Astra Zeneca no<br />

A phase I, open-label, study of the safety, tolerability and<br />

pharmacokinetics of pazopanib in combination with<br />

gemcitabine and gemcitabine plus cisplatin for advanced<br />

solid tumors<br />

solid tumors I GlaxoSmithKline no<br />

A randomized, double-blind, placebo-controlled study<br />

comparing aflibercept versus placebo on the QTc interval<br />

in Cancer patients treated with docetaxel.<br />

solid tumors I Sanofi-Aventis<br />

Deutschland GmbH<br />

no<br />

A Phase I, Open-Label study of the safety, tolerability,<br />

and pharmacokinetics of Angiocal (PRS-050-PEG40) in<br />

patients with solid tumor<br />

Open label, dose escalation trial of oral 4SC-205 in<br />

patients with advanced malignancies: First-in-man study<br />

of a newly developed, oral inhibitor of kinesin-spindle<br />

protein, EG 5 (AEGIS)<br />

An open phase I single dose escalation study of two<br />

dosing schedules of BI811283 administered<br />

intravenously over 24 h continuous infusion in patients<br />

with advanced solid tumor with repente administration in<br />

patients with clinical benefit<br />

A Phase I, open label study evaluating the<br />

Pharmacokinetics of components of S-1 in patients with<br />

varying degrees of renal function (S-1111)<br />

solid tumors I Pieris AG no<br />

solid tumors I 4SC AG no<br />

Solid tumors I/IIa Boehringer no<br />

Solid tumors I Taiho no


A Phase I Dose Escalation study on the tolerability and<br />

activity of TriN 2755 in patients with advanced solid<br />

tumors and sarcomas using two different dosage regimes<br />

Phase II double-blind placebo-controlled trial of CY-503<br />

in patients with chemotherapy-refractory metastatic<br />

colorectal cancer<br />

Solid tumors I TriN no<br />

Colorectal cancer II CYTAVIS no<br />

Bayer Correct BAY73-4506 / 14387 Met. CRC III Bayer Health Care no<br />

Maurice EMR 200020-34 CRC II Merck no<br />

Merck OPUS EMR 62202-047 CRC II Merck no<br />

Schering PTK I CRC III Schering No<br />

Schering PTK II CRC III Schering No<br />

Petacc8 Colon-Ca III Pierre Fabre no<br />

Astra Zeneca Horizon-II Met. CRC II Astra Zeneca no<br />

Celim Met. Hep. CRC II AIO no<br />

Amgen 20050181 Panitumumab Met. CRC II Amgen no<br />

Roche Beat Met. CRC n.a. Roche no<br />

Merck MK-0646 Met. CRC I Merck no<br />

Velour Met. CRC III Sanofi Aventis no<br />

Biweekly Cetuximab in combination with FOLFOX-6 as<br />

first-line treatment in metastatic colorectal cancer<br />

patients (CEBIFOX)<br />

Tolerability and efficacy of bevacizumab, capecitabine<br />

and oxaliplatin as first-line therapy in patients with<br />

metastatic colorectal cancer (NERO)<br />

Phase-II-study, radio-chemo-therapy (neoadjuvant) with<br />

Capecitabine and Oxaliplatin and Bevacizumab for<br />

patients with advanced rectum-ca (translational research<br />

project) BEV-XELOX-RT)<br />

Colorectal cancer II Universitätsklinikum<br />

<strong>Essen</strong><br />

Tanja Trarbach,<br />

Dr. med., MSc<br />

(IIT)<br />

Colorectal cancer II Roche Tanja Trarbach,<br />

Dr. med., MSc<br />

rectum cancer II Universitätsklinikum<br />

Schleswig Holstein<br />

Prof. Dr. med. Dunst.<br />

Lübeck<br />

(IIT)


A prospective angiogenic imaging study with DCE-MRI<br />

and DCE-USI in patients with colorectal cancer and liver<br />

metastases receiving sunitinib in addition to 5-FU, folic<br />

acid and irinotecan (FOLFIRI) as 1 st line therapy(C-II-<br />

005)<br />

Colorectal Cancer II CESAR Prof. Dr. med. M. E.<br />

Scheulen<br />

(IIT)<br />

AIO KRK 0204 CRC I7II AIO no<br />

CEBIFOX CRC II Merck, Sanofi Aventis no<br />

AIO KRK 0504


Two-arm, randomized, open-label, phase IIIb study<br />

investigating the safety of 2 hour i.p. infusion of<br />

catumaxomab with and without prednisolone<br />

premedication in patients with malignant ascites due to<br />

epithelial cancer<br />

AMGEN 20050244<br />

malignant ascites due to<br />

epithelial cancer<br />

Bone metastasis,<br />

advanced Cancer<br />

(excluding Breast and<br />

Prostate) or Multiple<br />

Myeloma<br />

IIIb Fresenius Biotech GmbH no<br />

III AMGEN no<br />

Phase II study to evaluate Glivec (Imatinib Mesylate) to<br />

induce protression arrest in aggressive fibromatosis /<br />

desmoids tumors not amenable to surgical resection with<br />

R0 intent or accompanied by unacceptable function loss<br />

Desmoid Tumors II IIT Prof. Peter Hohenberger,<br />

Mannheim<br />

Saladax<br />

Bayer REASON<br />

Valuation of Eligibility of<br />

5-FU-concentration in<br />

clinical routine<br />

Ovarian Cancer/<br />

Prostate Cancer<br />

N/A Saldax Biomedical no<br />

II Bayer no<br />

Bingo Advanced biliary cancer II Institut Gustave Roussy,<br />

France<br />

no<br />

SPOT Oesophageal Cancer I/II Sanofi-Aventis no<br />

Pilot-Study of dose-intensified radiotherapy according to<br />

PET-CT in combination with induction- and simultaneous<br />

chemotherapy (SPOT)<br />

Oesophageal Cancer I/II Universitätsklinikum<br />

<strong>Essen</strong><br />

Prof. Dr. med. Martin<br />

Stuschke (IIT)<br />

HD-PEI +/- NESF<br />

met. „poor prognosis“<br />

germ cell tumor<br />

II Amgen no<br />

Phase I/II study with temsirolimus versus no add-on in<br />

patients with castration resistant prostate cancer (CRPC)<br />

receiving first-line Docetaxel chemotherapy (C-II-007)<br />

Positron-Emissions-Tomographie-gesteuerte Therapie<br />

aggressiver Lymphome (PETAL)<br />

Prostate Cancer I/II CESAR Prof. Dr. med. M. E.<br />

Scheulen<br />

(IIT)<br />

Aggressive Lymphome III German Cancer Aid Prof. Dr. U. Dührsen


Valuation of Eligibility of 5-FU-concentration in clinical<br />

routine (SALADAX)<br />

Observational Study to explore dermatological side<br />

effects of patients receiving an Anti-EGFR therapy<br />

multiple N/A Universitätsklinikum<br />

<strong>Essen</strong><br />

Skin N/A Universitätsklinikum<br />

<strong>Essen</strong><br />

Tanja Trarbach,<br />

Dr. med., MSc<br />

(IIT)<br />

Tanja Trarbach,<br />

Dr. med., MSc (IIT)<br />

Pacet-Cup Unknown Primary II AIO no

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