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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193622
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 17, 2010
Genentech, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Neoplasms, Unknown Primary Drug: Bevacizumab Drug: Erlotinib Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Bevacizumab + Erlotinib

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
Study Start Date : April 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Time to progression
  2. Overall survival
  3. Overall tolerability
  4. Overall toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193622

Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results: Identifier: NCT00193622     History of Changes
Other Study ID Numbers: SCRI UNKPRI 15
AVF 2968s
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action