NCT00047762

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2002

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2004

First QC Date

October 16, 2002

Last Update Submit

June 23, 2005

Conditions

Colorectal Cancer

Interventions

Erlotinib (aka Tarceva or OSI-774)DRUG
Bevacizumab (aka Avastin or Rhu MAb VEGF)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Indiana University Cancer Pavilion

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231-1000, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246-2006, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Erlotinib HydrochlorideBevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2002

First Posted

October 18, 2002

Study Start

October 1, 2002

Last Updated

June 24, 2005

Record last verified: 2004-11

Locations

US(3)