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A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Phase 2
18 Years
Not Enrolling
Neoplasms, Unknown Primary

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Trial Information

A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Upon determination of eligibility, patients will be receive:

- Bevacizumab + Erlotinib

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.

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

January 2009

Related Keywords:

  • Neoplasms, Unknown Primary
  • Neoplasms
  • Carcinoma
  • Neoplasms, Unknown Primary