A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- NCT01184287
- Lead Sponsor
- Tamir Biotechnology, Inc.
- Brief Summary
The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age greater than 18 years
- ECOG less than 2
- Estimated survival of greater than 12 weeks
- Prior systemic chemotherapy for locally advanced or metastatic NSCLC
- Use of any investigational agent within 28 days prior to registration
- Known hypersensitivity to any of the study drugs
- Brain metastases or leptomeningeal disease
- History of prior malignancy within the past three years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ranpirnase Ranpirnase All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
- Primary Outcome Measures
Name Time Method Response 4 or more months To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 2 years To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Survival 2 years To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Trial Locations
- Locations (6)
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Sletten Cancer Specialists
🇺🇸Great Falls, Montana, United States
Van Andel Research Institute
🇺🇸Grand Rapids, Michigan, United States
The Cancer Institute at NYU Langone Medical Center
🇺🇸New York, New York, United States
Tri-county Hematology-Oncology Associates, Inc
🇺🇸Canton, Ohio, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States