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

Tracking Information
First Received Date ^ICMJE	October 16, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	October 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Safety/Efficacy Study
Condition ^ICMJE	Colorectal Cancer
Intervention ^ICMJE	Drug: Erlotinib (aka Tarceva or OSI-774) Drug: Bevacizumab (aka Avastin or Rhu MAb VEGF)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047762
Responsible Party
Study ID Numbers ^ICMJE	OSI2520g
Study Sponsor ^ICMJE	Genentech
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genentech
Verification Date	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP