Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is test the safety of Tarceva, find the best dose, and see what effects (good and bad) it has on you and your colorectal cancer. The effects of Tarceva will be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without Bevacizumab.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

Subjects must fulfill all of the following criteria to be eligible for study entry:

• Signed informed consent

• At least 18 years of age

• Histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum

Resected or biopsied primary tumors or metastatic site will serve as the basis for histologic confirmation.

• Measurable disease (defined as at least one dimension >2 cm [>1 cm on spiral CT scans])

• ECOG performance status of 0 or 1

• Life expectancy >3 months

• Use of an effective means of contraception in men and in women of childbearing potential

• Ability to comply with study and follow-up procedures