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OpenTrials
Completed

NCT Number: NCT00193622

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

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.

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Key information

Conditions

Neoplasms, Unknown Primary Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, patients will be receive:

  • Bevacizumab + Erlotinib

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

Erlotinib

Drug

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Time to progression

  2. Overall survival

  3. Overall tolerability

  4. Overall toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Sep 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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