Back to resultsSafety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Erlotinib (aka Tarceva or OSI-774)
Bevacizumab (aka Avastin or Rhu MAb VEGF)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility 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
Sites / Locations
- Indiana University Cancer Pavilion
- Johns Hopkins Oncology Center
- Mary Crowley Medical Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00047762
Brief Title
Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Erlotinib (aka Tarceva or OSI-774)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (aka Avastin or Rhu MAb VEGF)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Indiana University Cancer Pavilion
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2006
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
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