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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047762
Recruitment Status : Completed
First Posted : October 18, 2002
Last Update Posted : June 24, 2005
Information provided by:
Genentech, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (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
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047762

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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.
Layout table for additonal information Identifier: NCT00047762    
Other Study ID Numbers: OSI2520g
First Posted: October 18, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2004
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action