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Trial Title:
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
NCT ID:
NCT00150657
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Bevacizumab
Carboplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
bevacizumab
Intervention type:
Drug
Intervention name:
carboplatin
Intervention type:
Drug
Intervention name:
gemcitabine
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
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Providence Cancer Institute
Address:
City:
Southfield
Zip:
48075
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael J Kraut, MD
Phone:
248-849-8155
Email:
mkraut@providence-hospital.org
Contact backup:
Last name:
Howard Terebelo, DO
Phone:
248-552-0620
Investigator:
Last name:
Michael J Kraut, MD
Email:
Principal Investigator
Investigator:
Last name:
Howard Terebelo, DO
Email:
Sub-Investigator
Investigator:
Last name:
Anibal Drelichman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Robert Bloom, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lyle Goldman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Judie Goodman, DO
Email:
Sub-Investigator
Start date:
November 2004
Lead sponsor:
Agency:
St. John Providence Health System
Agency class:
Other
Collaborator:
Agency:
Genentech, Inc.
Agency class:
Industry
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
St. John Providence Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00150657
