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

This study has been completed.
Information provided by:
Genentech, Inc. Identifier:
First received: October 16, 2002
Last updated: June 23, 2005
Last verified: November 2004
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.

Condition Intervention Phase
Colorectal Cancer
Drug: Erlotinib (aka Tarceva or OSI-774)
Drug: Bevacizumab (aka Avastin or Rhu MAb VEGF)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarceva, 5-Fluorouracil, Leucovorin, and Irinotecan

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Study Start Date: October 2002

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00047762

United States, Indiana
Indiana University Cancer Pavilion
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-1000
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246-2006
Sponsors and Collaborators
Genentech, Inc.
  More Information Identifier: NCT00047762     History of Changes
Other Study ID Numbers: OSI2520g 
Study First Received: October 16, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on May 26, 2016