A Phase III, Multicenter, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab) in Combination With Standard Chemotherapy in Subjects With Metastatic Colorectal Cancer

Genentech, Inc.0 sitesSeptember 2000

ConditionsColorectal Cancer

DrugsAvastin (bevacizumab)

Overview

Phase: Phase 3
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 is a multicenter, Phase III, randomized, active-controlled trial to evaluate the efficacy and safety of rhuMAb VEGF (Avastin) added to the standard first-line chemotherapy used to treat metastatic colorectal cancer. This trial will enroll approximately 900 subjects with histologically confirmed, previously untreated, bi-dimensionally measurable metastatic colorectal cancer.

Registry

clinicaltrials.gov

Start Date

September 2000

End Date

April 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
•Histologically confirmed 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)
•ECOG performance status of 0 or 1
•Use of an effective means of contraception in women of childbearing potential
•Life expectancy of \>3 months
•Willingness and capability to be accessible for follow-up until death or study termination by Genentech

Exclusion Criteria

•Prior 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
•Radiation therapy within 14 days prior to Day 0
•Prior biotherapy for colorectal cancer
•Evidence of clinically detectable ascites on Day 0
•Other invasive malignancies within 5 years prior to 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, any brain metastases, or history of stroke)
•Active infection requiring parenteral antibiotics on Day 0