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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: bevacizumab
Type: Drug
Name: carboplatin
Type: Drug
Name: gemcitabine
Type: Drug
Overall Status
Recruiting
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
- 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
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
- 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Providence Cancer Institute
Southfield, Michigan, United States
Status: Recruiting
Contact: Michael J Kraut, MD - 248-849-8155 - mkraut@providence-hospital.org
Start Date
November 2004
Sponsors
St. John Providence Health System
Source
St. John Providence Health System
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page