Avastin and Tarceva for Upper Gastrointestinal Cancers
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|ClinicalTrials.gov Identifier: NCT00350753|
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : July 15, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Gallbladder Cancer||Drug: Erlotinib and bevacizumab||Phase 2|
- To determine the median time to progression (TTP) and response rate (RR) of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas, refractory or intolerant to standard systemic therapy.
- To determine safety, tolerability and toxicity.
- To determine median and overall survival (OS).
- To correlate efficacy of treatment with the expression of tumor markers obtained in serum (EFGR, bFGF, p-VEGF-A, and sVEGF-R2), in paraffin embedded tumor tissue (micro vessel density (MVD), and expression of VEGFR and EGFR, after immunostaining), and in fresh frozen tumor biopsies (micro array-based analyses of patterns of gene expression).
Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
U.S. FDA Resources
|Experimental: Erlotinib and bevacizumab||
Drug: Erlotinib and bevacizumab
Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days
- Objective response by RECIST criteria [ Time Frame: From time of treatment start to response evaluation ]
- Time to progression [ Time Frame: 1 year ]
- Toxicity evaluated by NCI-CTCae version 3.0 [ Time Frame: 1 year ]
- Survival [ Time Frame: 1 year ]
- Biomarkers [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350753
|Copenhagen, Denmark, 2100|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Århus, Denmark, 8000 C|
|Principal Investigator:||Ulrik Lassen, MD., PH.D.||Rigshospitalet, Dept. of Oncology|