A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer
OBJECTIVES: I. Compare the survival of patients with previously untreated metastatic
colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan with or
without SU5416. II. Compare the antitumor efficacy of these regimens in these patients. III.
Evaluate the additional measures of clinical benefit in patients treated with these
regimens. IV. Determine the relative safety profile of these regimens in these patients. V.
Assess quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to ECOG performance status (0 vs 1), baseline lactate dehydrogenase (normal vs
elevated), and treatment regimen. Patients are randomized to 1 of 2 treatment arms by 2
different regimens (Saltz vs de Gramont). Regimen I (Saltz): Arm IA: Patients receive SU5416
IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Patients also
receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 5-10 minutes, and
fluorouracil IV over 5-10 minutes on days 1, 8, 15, and 22. Arm IIA: Patients receive
irinotecan, leucovorin calcium, and fluorouracil as in arm I. Treatment in both arms repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity. Regimen II (de
Gramont): Arm IB: Patients receive SU5416 as in arm IA. Patients also receive irinotecan IV
over 30-90 minutes on days 1, 15, and 29 and leucovorin calcium IV over 2 hours and
fluorouracil IV over 2 hours on days 1, 2, 15, 16, 29, and 30. Arm IIB: Patients receive
irinotecan, leucovorin calcium, and fluorouracil as in arm IB. Treatment in both arms
repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the beginning of each course, and then at the
end of treatment. Patients are followed at 1 month and then every 2 months for 4 years.
PROJECTED ACCRUAL: A total of 1,270 patients (635 per treatment arm) will be accrued for
this study within 2 years.
Primary Purpose: Treatment
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|