Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Phase 2

Completed

• Conditions: Neoplasms, Unknown Primary

• Registration Number: NCT00193622
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.

Detailed Description

Upon determination of eligibility, patients will be receive:

* Bevacizumab + Erlotinib

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2009-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Carcinoma of unknown primary site confirmed by biopsy
• Measurable disease
• ECOG performance status must be 0-1
• Adequate bone marrow, liver and kidney
• Understand the nature of this study and give written informed consent.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Age< 18 years
• May not have received EGFR inhibitors
• History of acute myocardial infarction within 6 months
• Clinically significant cardiovascular disease
• Moderate to severe peripheral vascular disease.
• History of stroke within 6 months
• History of abdominal fistula, perforation, or abscess within 6 months
• Active concurrent infections
• Serious underlying medical conditions
• Active brain metastases
• Women who are pregnant or lactating.
• PEG or G-tube
• Proteinuria
• Any nonhealing wound, ulcer, or bone fracture.
• Any clinical evidence or history of bleeding, clotting or coagulopathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Time to progression
Overall survival
Overall tolerability
Overall toxicity