Avastin and Tarceva for Upper Gastrointestinal Cancers

Sponsor
Rigshospitalet, Denmark
Study ID
NCT00350753
Phase
PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma
  • Gallbladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Months - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.

Key Dates

First listed
Jul 11, 2006
Start date
Jun 30, 2006
Status verified
Jul 2009
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
126 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib and bevacizumab

Primary Outcome Measure

Objective response by RECIST criteria [ Time Frame: From time of treatment start to response evaluation ]

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