Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

St. John Providence Health System1 site in 1 country45 target enrollmentNovember 2004

ConditionsNon-Small Cell Lung Cancer

Drugsbevacizumab carboplatin gemcitabine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: St. John Providence Health System
Enrollment: 45
Locations: 1
Primary Endpoint: time to progression
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

St. John Providence Health System

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