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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00047762
First received: October 16, 2002
Last updated: June 23, 2005
Last verified: November 2004
  Purpose

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:

Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047762

Locations
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
  More Information

No publications provided

ClinicalTrials.gov 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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Bevacizumab
Erlotinib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014