Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer.
Drug: irinotecan hydrochloride
Drug: oglufanide disodium
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs. 5-FU With IM862 With Cross-Over to CPT-11 vs. CPT-11 With IM862|
|Study Start Date:||November 1999|
|Study Completion Date:||November 2001|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare the efficacy of fluorouracil with or without IM-862 in terms of progression free survival in patients with previously untreated or recurrent metastatic adenocarcinoma of the colon or rectum. II. Determine the toxicity of IM-862 and fluorouracil in these patients. III. Determine the efficacy of IM-862 in combination with irinotecan in terms of progression free survival in patients who have disease progression after receiving fluorouracil. IV. Obtain preliminary data on molecular markers of response and time to progression by determining levels of genes involved in adhesion, angiogenesis, apoptosis, and drug resistance prior to and during chemotherapy. V. Determine the molecular correlates for response and time to progression through analysis of serum and urine markers of angiogenesis, such as vascular endothelial growth factor and fibroblast growth factor, in patients treated with IM-862 in combination with fluorouracil or irinotecan. VI. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomized to one of two treatment arms: Arm I: Patients receive fluorouracil IV continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and IM-862, and then receive irinotecan IV over 90 minutes weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression. Arm II: Patients receive fluorouracil as in arm I and placebo intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and placebo, and then receive irinotecan and IM-862 as in arm I on days 1-42. Courses repeat every 6 weeks in the absence of disease progression. Quality of life is assessed prior to study, and then prior to every course during study. Patients are followed for a minimum of 6 months.
PROJECTED ACCRUAL: A total of 66 patients (33 per arm) will be accrued for this study within 26-27 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006037
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|