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Program discontinued
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranpirnase | Experimental | All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranpirnase | Drug | Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy | 2 years |
| Survival | To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | United States | ||
| Van Andel Research Institute |
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| 2 years |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C058703 | ranpirnase |
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