Colorectal Cancer Clinical Trials Spotlight - The University Of ...

THE UNIVERSITY OF KANSAS CANCER CENTER
Two colorectal cancer clinical trials
now open
Additional phase I third-line therapy trial to open soon
Joaquina Baranda, MD
Principal Investigator
To treat advanced colon cancer, patients receive either FOLFOX or FOLFIRI, both
chemotherapy regimens, as a standard, first-line therapy. Many patients also receive
bevacizumab, an antibody that attacks the tumor cells’ ability to produce new blood vessels.
Initial trials have shown that when bevacizumab is added to chemotherapy, it increases the
chances of shrinking the tumor and prolonging the patient’s life, when compared to giving
chemotherapy alone.
In a majority of patients, their tumors become resistant to the selected chemotherapy
regimen. They progress to the second-line therapy, which involves a different regimen of
chemotherapy drugs.
However, the second-line therapy often eventually fails as well.
Two phase III trials now open at The University of Kansas Cancer Center could show
which combinations of chemotherapy agents and medications offer patients the best
outcomes. The principal investigator for these trials is Joaquina Baranda, MD. A phase I
trial studying a third-line therapy is slated to open soon. The investigator-initiated trial
is led by Dr. Baranda.

For Physicians and Health Care Professionals
CLINICAL TRIALS SPOTLIGHT
Combinations of chemotherapy agents and
medications to be studied to determine efficacy
for colorectal cancer patients
Phase III clinical trial:
Phase III Trial of Irinotecan/5-
FU/Leucovorin or Oxaliplatin/5-
FU/Leucovorin with Bevacizumab, or
Cetuximab (C225) for Patients with
Untreated Metastatic Adenocarcinoma
of the Colon or Rectum
This randomized phase III trial is
studying cetuximab and/or bevacizumab
when given together with combination
chemotherapy. The trial’s primary
purpose is to compare how well the
chemotherapy agents work in treating
patients with metastatic colorectal
cancer.
Eligibility
Both men and women older than
18 who have a histologically
or cytologically confirmed
adenocarcinoma of the colon or
rectum. Patients with resected primary
tumors who have documented
metastases are eligible. Patients
must have a wild-type KRAS gene
determined by the SWOG Solid
Tumor Repository laboratory or by
a local CLIA-certified laboratory.
Patients with a mutation in the K-ras
gene are not eligible.
Phase III clinical trial:
Phase III Trial of Irinotecan-Based
Chemotherapy Plus Cetuximab
(NSC-714682) With or Without
Bevacizumab (NSC-704965) as
Second-Line Therapy for Patients
With Metastatic Colorectal
Cancer Who Have Progressed on
Bevacizumab with either FOLFOX,
OPTIMOX or XELOX
This randomized phase III trial studies
irinotecan and cetuximab, combined
with bevacizumab, to see how well it
works compared with giving irinotecan
and cetuximab alone in treating
patients with metastatic colorectal
cancer that progressed during first-line
therapy.
Eligibility
Both men and women older than
18 who have a histologically or
cytologically confirmed colorectal
cancer, meeting the following criteria:
• Metastatic disease (confirmation
may be from either the primary
tumor or a metastasis)
• Progressed on first-line therapy
comprising bevacizumab and
FOLFOX, OPTIMOX, or XELOX
• Wild-type KRAS gene
To refer a patient or consult with a specialist, call
913.588.5862 or 877.588.5862.
Visit kucancercenter.org/colontrial for more information.
Dr. Baranda discusses these colorectal cancer trials in
more detail. (video)
Phase I clinical trial:
Phase I Trial of Irinotecan and
BKM120 in Previously Treated
Advanced Colorectal Cancer
A third trial, scheduled to open soon,
is designed to test the new drug
BKM120. The goal of the trial is to help
researchers learn whether BKM120
could have an impact on both the
KRAS wild-type KRAS or KRAS
mutant types of colon cancers, when
combined with irinotecan. This is an
investigator-initiated trial led by Dr.
Baranda.
This phase I trial combines irinotecan
and BKM120 in patients with advanced
colorectal cancer who have failed on or
have become intolerant of at least one
line of therapy for advanced colorectal
cancer and who are candidates for
irinotecan therapy. This trial is designed
to identify a maximum tolerated dose
for irinotecan and BKM120 used in
combination in the treatment of
advanced colorectal cancer.
Eligibility
Both men and women older than 18
who have histologically or cytologically
confirmed metastatic or unresectable
adenocarcinoma of the colon or rectum.
Patients who have advanced colorectal
cancer who have become resistant
or intolerant of at least one line of
chemotherapy regimen are eligible in
this trial. They must also meet the
following criteria:
• Patients must have adequate liver,
renal and marrow function.
• At least 28 days must have elapsed
since the last dose of most recent
regimen of chemotherapy and
biologic agents used.