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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by St John Health Oncology Research Consortium.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Genentech
Eli Lilly and Company
Information provided by:
St John Health Oncology Research Consortium
ClinicalTrials.gov Identifier:
NCT00150657
First received: September 6, 2005
Last updated: November 28, 2005
Last verified: September 2005
History of Changes

September 6, 2005
November 28, 2005
November 2004
Not Provided
time to progression
Same as current
Complete list of historical versions of study NCT00150657 on ClinicalTrials.gov Archive Site
  • response rate
  • median survival
  • one year survival
  • two year survival
  • toxicity
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab
  • Drug: carboplatin
  • Drug: gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Michael J Kraut, MD 248-849-3541 mkraut@providence-hospital.org
Contact: Jaswinder Grewal, PhD 248-849-5337 jgrewal@providence-hospital.org
United States
 
NCT00150657
AVF3121s
Not Provided
Not Provided
St John Health Oncology Research Consortium
  • Genentech
  • Eli Lilly and Company
Principal Investigator: Michael J Kraut, MD Providence Cancer Institute
St John Health Oncology Research Consortium
September 2005

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