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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00150657
Recruitment Status : Unknown
Verified September 2005 by St. John Providence Health System.
Recruitment status was:  Recruiting
First Posted : September 8, 2005
Last Update Posted : November 29, 2005
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by:
St. John Providence Health System

Study Description
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Brief Summary:
  • this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added
  • the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)
  • all patients receive all three drugs; there is no placebo

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: bevacizumab Drug: carboplatin Drug: gemcitabine Phase 2

Detailed Description:
  • Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.
  • Patients with brain metastases, squamous histology, or hemoptysis are excluded.
  • All patients must give informed consent.
  • Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. time to progression

Secondary Outcome Measures :
  1. response rate
  2. median survival
  3. one year survival
  4. two year survival
  5. toxicity

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
  • Stage IV disease or stage IIIB with a malignant pleural effusion
  • measurable or evaluable disease
  • Performance status 0 or 1 (ECOG)
  • adequate renal, hepatic, and bone marrow function
  • adequate recovery from previous surgery or radiotherapy
  • informed consent

Exclusion Criteria:

  • brain metastases
  • squamous (epidermoid) histology
  • hemoptysis
  • central airway disease
  • Pancoast tumors
  • previous chemotherapy or biologic therapy for lung cancer
  • prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
  • pregnant or nursing women
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00150657


Contacts
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Contact: Michael J Kraut, MD 248-849-3541 mkraut@providence-hospital.org
Contact: Jaswinder Grewal, PhD 248-849-5337 jgrewal@providence-hospital.org

Locations
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United States, Michigan
Providence Cancer Institute Recruiting
Southfield, Michigan, United States, 48075
Contact: Michael J Kraut, MD    248-849-8155    mkraut@providence-hospital.org   
Contact: Howard Terebelo, DO    248-552-0620      
Principal Investigator: Michael J Kraut, MD         
Sub-Investigator: Howard Terebelo, DO         
Sub-Investigator: Anibal Drelichman, MD         
Sub-Investigator: Robert Bloom, MD         
Sub-Investigator: Lyle Goldman, MD         
Sub-Investigator: Judie Goodman, DO         
Sponsors and Collaborators
St. John Providence Health System
Genentech, Inc.
Eli Lilly and Company
Investigators
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Principal Investigator: Michael J Kraut, MD Providence Cancer Institute
More Information
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ClinicalTrials.gov Identifier: NCT00150657    
Other Study ID Numbers: AVF3121s
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Bevacizumab
Carboplatin
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors