Study Stopped
Program discontinued
A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer
1 other identifier
interventional
N/A
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
6 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2010
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedSeptember 2, 2015
August 1, 2015
August 17, 2010
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response
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
4 or more months
Secondary Outcomes (2)
Progression Free Survival (PFS)
2 years
Survival
2 years
Study Arms (1)
ranpirnase
EXPERIMENTALAll patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
Interventions
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- ECOG less than 2
- Estimated survival of greater than 12 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Van Andel Research Institute
Grand Rapids, Michigan, 49503, United States
Sletten Cancer Specialists
Great Falls, Montana, 59405, United States
The Cancer Institute at NYU Langone Medical Center
New York, New York, 10016, United States
Tri-county Hematology-Oncology Associates, Inc
Canton, Ohio, 44718, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2010
First Posted
August 18, 2010
Last Updated
September 2, 2015
Record last verified: 2015-08