Avastin and Tarceva for Upper Gastrointestinal Cancers

Cholangiocarcinoma Clinical Trial

Official title: A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Primary Objective

• 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.

Secondary Objective

• 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).

Treatment:

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Gallbladder Cancer

• NCT number: NCT00350753
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Completion date: June 2009