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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193622
First received: September 12, 2005
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Neoplasms, Unknown Primary
Drug: Bevacizumab
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Time to progression
  • Overall survival
  • Overall tolerability
  • Overall toxicity

Estimated Enrollment: 50
Study Start Date: April 2004
Study Completion Date: January 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Bevacizumab + Erlotinib
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193622

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193622     History of Changes
Other Study ID Numbers: SCRI UNKPRI 15, AVF 2968s
Study First Received: September 12, 2005
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014