Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
- Registration Number
- NCT00268489
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.
Secondary
* Determine the tumor response rate in these patients.
* Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.
* Determine the toxicity profile of this drug regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pemetrexed + bevacizumab bevacizumab Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years. pemetrexed + bevacizumab pemetrexed disodium Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.
- Primary Outcome Measures
Name Time Method Proportion of progression-free patients at 3 months at 3 months
- Secondary Outcome Measures
Name Time Method Response (complete and partial) as assessed by RECIST criteria Up to 5 years Progression-free survival Up to 5 years Time to treatment failure Up to 5 years Duration of response Up to 5 years Overall survival Up to 5 years
Trial Locations
- Locations (246)
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
Highland General Hospital at St. George's University School of Medicine
🇺🇸Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Scroll for more (236 remaining)Providence Cancer Center🇺🇸Anchorage, Alaska, United States