A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab), a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor, in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11

Genentech, Inc.0 sitesAugust 2000

ConditionsColorectal Cancer

DrugsAvastin (Bevacizumab)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Genentech, Inc.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This Phase II, multicenter, double-blind, randomized, active-controlled trial is designed to evaluate the efficacy and safety of rhuMAb VEGF (Avastin) when administered at a dose of 5 mg/kg every 2 weeks in combination with 5 FU (fluorouracil)/leucovorin versus 5 FU/leucovorin alone in subjects with previously untreated metastatic colorectal cancer who are not optimal candidates to receive first-line CPT-11 (irinotecan). A total of 48 doses of rhuMAb VEGF may be administered during this study (maximum of 96 weeks of therapy).

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

September 2003

Last Updated

12 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Age \>=18 years
•Use of an effective means of contraception in women of childbearing potential
•Histologically confirmed (resected or biopsied primary tumor) colorectal carcinoma with evidence of metastases (i.e., by radiographic imaging or biopsy)
•Ability to tolerate CT contrast dye.
•Bi-dimensionally measurable disease (minimum of two lesions)
•Life expectancy of \>3 months
•Willingness and capability to be accessible for follow-up until death
•In addition, subjects must meet at least one of the following criteria to be eligible for study entry: \*Age \>=65 years; \*ECOG performance status of 1 or 2; \*Albumin \<=3.5 g/dL; \*Prior radiotherapy to the abdomen or pelvis; and, \*in the opinion of the treating physician, not be an optimal candidate for first-line CPT-11

Exclusion Criteria

•Prior administration of chemotherapy other than adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole
•Administration of adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole completed \<=12 months prior to Day 0
•Administration of fluoropyrimidines as a radiosensitizer during pelvic radiotherapy for rectal cancer completed \<=12 months prior to Day 0
•Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
•Radiotherapy within 14 days prior to Day 0
•Prior administration of biotherapy for colorectal cancer
•Evidence of clinically detectable ascites prior to Day 0
•Other invasive malignancies within 5 years of Day 0 (other than basal cell carcinoma of the skin)
•History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases)
•Serious, nonhealing wound, ulcer, or bone fracture