Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
OSI Pharmaceuticals
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00553800
First received: November 5, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: bevacizumab
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Efficacy measure is progression free survival defined as the time from enrollment to documented progression of disease by radiologic imaging. [ Time Frame: Scans to be done after every 2nd cycle of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: every 3 weeks at day 1 physician exam and in between as needed ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: March 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab & Erlotinib
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
Drug: bevacizumab
Other Name: Other names: Avastin
Drug: Erlotinib
Other Name: Other name: Tarceva

Detailed Description:

There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
  • ECOG PS 0-1
  • 70 years of age or older
  • Must have measurable disease
  • ANC > 1500, platelets > 100,000
  • Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN
  • Able and willing to swallow and absorb oral medication
  • Able and willing to sign consent
  • Request archival diagnostic tissue for EGFR expression but not required

Exclusion Criteria:

  • Proteinuria as demonstrated by UPC ratio >/= 1.0
  • Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
  • Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
  • History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
  • Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
  • Current, ongoing treatment with full dose warfarin or equivalent
  • Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet activity
  • History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
  • Known CNS disease except for treated brain mets.
  • Squamous cell histology
  • Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives
  • History of hypertensive crisis or hypertensive encephalopathy
  • NYHA grade II or > CHF
  • History of MI within 6 months of enrollment
  • Major surgery, open biopsy, significant trauma within 28 days of enrollment
  • Pregnancy, lactation
  • Abdominal or other fistula, abcess, perforation
  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: NCT00553800

Locations
United States, New Jersey
AtlantiCare Regional Medical Center
Galloway, New Jersey, United States, 08205
Fox Chase Virtua Health Cancer Program at Memorial
Mount Holly, New Jersey, United States, 08060
United States, Pennsylvania
Paoli Hospital
Paoli, Pennsylvania, United States, 19301
Abramson Cnacer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Sponsors and Collaborators
Fox Chase Cancer Center
Genentech
OSI Pharmaceuticals
Investigators
Principal Investigator: Hossein Borghaei, DO Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00553800     History of Changes
Other Study ID Numbers: FER-TH-007
Study First Received: November 5, 2007
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
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 01, 2014