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

NCT ID: NCT00047762

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Erlotinib (aka Tarceva or OSI-774)

Intervention Type DRUG

Bevacizumab (aka Avastin or Rhu MAb VEGF)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Indiana University Cancer Pavilion

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OSI2520g

Identifier Type: -

Identifier Source: org_study_id