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 Providence Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by:
St. John Providence Health System
ClinicalTrials.gov Identifier:
NCT00150657
First received: September 6, 2005
Last updated: November 28, 2005
Last verified: September 2005
  Purpose
  • 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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab
Drug: carboplatin
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by St. John Providence Health System:

Primary Outcome Measures:
  • time to progression

Secondary Outcome Measures:
  • response rate
  • median survival
  • one year survival
  • two year survival
  • toxicity

Estimated Enrollment: 45
Study Start Date: November 2004
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00150657

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

Locations
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
Principal Investigator: Michael J Kraut, MD Providence Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150657     History of Changes
Other Study ID Numbers: AVF3121s
Study First Received: September 6, 2005
Last Updated: November 28, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Gemcitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014