NCT00456261

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	pemetrexed 500 mg/m2
DRUG	Gemcitabine	gemcitabine 1500 mg/m2
DRUG	Bevacizumab	bevacizumab 10mg/kg bevacizumab 15mg/kg
DRUG	Carboplatin	carboplatin AUC=5

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-02-01
• Completion: 2012-09-01
• First posted: 2007-04-04
• Last updated: 2022-05-03
• Results posted: 2013-02-27

Locations

18 sites across 1 country: United States