Colorectal Cancer
Conditions
Brief 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.
Interventions
DRUGErlotinib (aka Tarceva or OSI-774)
DRUGBevacizumab (aka Avastin or Rhu MAb VEGF)
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed