Trial of Poor Performance Status Patients (ToPPS)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- SCRI Development Innovations, LLC
- Study ID
- NCT00892710
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pemetrexed — DRUG500 mg/m2 IV given over 10 minutes every 21 days
- Bevacizumab — DRUG15 mg/kg IV every 21 days
- Carboplatin — DRUGAUC=5 IV every 21 days
Study Details
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.
Key Dates
- First listed
- May 4, 2009
- Start date
- Jun 30, 2009
- Status verified
- May 2015
- Primary completion
- Jul 31, 2014
- Completion
- May 31, 2015
Study Design
- Enrollment
- 172 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pemetrexed/Bevacizumab* Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days
- Experimental: Pemetrexed/Bevacizumab/Carboplatin* Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days * Carboplatin AUC=5 IV every 21 days
- Experimental: PemetrexedPemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: 18 months ]
Locations (27)
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