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First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC

Lung Cancer Clinical Trial

Official title:
A Randomized Phase II Trial of Pemetrexed/Gemcitabine/Bevacizumab or Pemetrexed/Carboplatin/Bevacizumab in the First-Line Treatment of Elderly Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Summary

This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.

Clinical Trial Description

Patients in this study will be assigned to one of 2 treatment groups. The selection of the treatment groups will be done randomly by a computer. The first group, Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. The second group, Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the occurrence of side effects from the treatment. Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see how well the cancer is responding to the treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00456261
Study type Interventional
Source SCRI Development Innovations, LLC
Contact
Status Completed
Phase Phase 2
Start date March 2007
Completion date September 2012
View Details
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