Status:

COMPLETED

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

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Neoplasms, Unknown Primary

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 rela...

Detailed Description

Upon determination of eligibility, patients will be receive: * Bevacizumab + Erlotinib

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2004

Trial Type :

INTERVENTIONAL

End Date :

January 1 2009

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00193622

Start Date

April 1 2004

End Date

January 1 2009

Last Update

September 17 2010

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