Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Phase 2

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00150657
• Lead Sponsor: St. John Providence Health System

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

Study Timeline

• Study Start: 2004-11
• Status Verified: 2005-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Last Update Submitted: 2005-11-28
• Last Update Posted: 2005-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
time to progression

Secondary Outcome Measures

Name	Time	Method
response rate
median survival
one year survival
two year survival
toxicity

Trial Locations

Locations (1)

Providence Cancer Institute; 🇺🇸 Southfield, Michigan, United States