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

This study has been completed.

First Received on October 16, 2002. Last Updated on 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: Fluorouracil 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

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 February 12, 2012