Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer - Full Text View

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

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Erlotinib Erlotinib hydrochloride Bevacizumab Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Safety/Efficacy Study

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

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

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

Study placed in the following topic categories:

Erlotinib

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Irinotecan

Leucovorin

Bevacizumab

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Angiogenesis Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Angiogenesis Modulating Agents

Growth Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

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