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

This study has been completed.

First Received: October 16, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00047762

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 I

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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib Bevacizumab

U.S. FDA Resources

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

Study ID Numbers:	OSI2520g
Study First Received:	October 16, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00047762 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Erlotinib
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Enzyme Inhibitors
Bevacizumab
Intestinal Diseases
Protein Kinase Inhibitors

Angiogenesis Inhibitors
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on March 18, 2010