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

Genentech

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Erlotinib (aka Tarceva or OSI-774); Drug: Bevacizumab (aka Avastin or Rhu MAb VEGF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00047762

OSI2520g

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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