Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
NCT ID: NCT00150657
Last Updated: 2005-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2004-11-30
Brief Summary
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* 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
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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bevacizumab
carboplatin
gemcitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
St. John Providence Health System
OTHER
Principal Investigators
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Michael J Kraut, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Cancer Institute
Locations
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Providence Cancer Institute
Southfield, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Michael J Kraut, MD
Role: primary
Howard Terebelo, DO
Role: backup
Other Identifiers
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AVF3121s
Identifier Type: -
Identifier Source: org_study_id