NCT00892710

Trial of Poor Performance Status Patients (ToPPS)

Randomized Phase II Trial of Pemetrexed vs. Pemetrexed/Bevacizumab vs. Pemetrexed/Carboplatin/Bevacizumab in Patients With Stage IIIB/IV Non-Small-Cell Lung Cancer and ECOG Performance Status 2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Detailed description

This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	500 mg/m2 IV given over 10 minutes every 21 days
DRUG	Bevacizumab	15 mg/kg IV every 21 days
DRUG	Carboplatin	AUC=5 IV every 21 days

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-07-01
• Completion: 2015-05-01
• First posted: 2009-05-04
• Last updated: 2015-05-15
• Results posted: 2015-05-15

Locations

27 sites across 1 country: United States