Recurrent Rectal Cancer Clinical Trial
Official title:
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) 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 is studying giving irinotecan and cetuximab together 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. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.
PRIMARY OBJECTIVES:
I. Compare progression-free survival of patients with metastatic colorectal cancer that
progressed on first-line therapy comprising bevacizumab and FOLFOX, OPTIMOX, or XELOX
treated with irinotecan hydrochloride-based chemotherapy and cetuximab with vs without
bevacizumab.
II. Compare overall survival of patients treated with these regimens. III. Compare objective
tumor response (confirmed and unconfirmed, complete and partial response) in patients with
measurable disease treated with these regimens.
IV. Compare the tolerability and safety profile of these regimens in these patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
Zubrod performance status (0 vs 1 or 2), discontinuation of oxaliplatin during first-line
therapy (yes vs no), planned concurrent chemotherapy (FOLFIRI vs single-agent irinotecan
hydrochloride), and time from last dose of bevacizumab (14-42 days vs >= 43 days).
All patients receive 1 of the following chemotherapy regimens:
SINGLE AGENT IRINOTECAN HYDROCHLORIDE: Patients receive irinotecan hydrochloride
intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.
FOLFIRI: Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium
IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours on days 1 and 2.
Treatment repeats every 14 days in the absence of disease progression or unacceptable
toxicity.
Patients are then randomized to 1 of 3 treatment arms.
ARM I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above
and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon
chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above
and cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1.
Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of
disease progression or unacceptable toxicity.
ARM III (closed to accrual as of 4/20/2009): Patients receive single-agent irinotecan
hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive
a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses
repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years and
then once a year for 3 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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