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. 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
Genentech, Inc.
Eli Lilly and Company
Information provided by:
St. John Providence Health System

September 6, 2005
September 8, 2005
November 29, 2005
November 2004
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time to progression
Same as current
Complete list of historical versions of study NCT00150657 on Archive Site
  • response rate
  • median survival
  • one year survival
  • two year survival
  • toxicity
Same as current
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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
  • 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
  • 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
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab
  • Drug: carboplatin
  • Drug: gemcitabine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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St. John Providence Health System
  • Genentech, Inc.
  • Eli Lilly and Company
Principal Investigator: Michael J Kraut, MD Providence Cancer Institute
St. John Providence Health System
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP