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The goals of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xcytrin® (motexafin gadolinium) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motexafin gadolinium and pemetrexed | Drug | 1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 month progression free survival | proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Time to progression is defined as the time from first dose of MGd to first evidence of progression. | up to 2 years |
| Overall survival | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Edelman, MD | University of Maryland, Greenbaum Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Beach | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15684606 | Background | Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8. | |
| 15627019 | Background | Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98. |
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|
| up to 2 years |
| Progression free survival | Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death. | up to 2 years |
| Response rate (CR+PR) by RECIST criteria | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment. | up to 2 years |
| Duaration of reponse (CR+PR) | Duration of response (CR + PR) is defined as the time from first response to the time of disease progression. | up to 2 years |
| Clinical benefit rate (CR+PR+SD) | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment | up to 2 years |
| Safety and tolerability of MGd and pemetrexed | All patients who receive any MGd will be included in the safety summaries and analyses | up to 2 years |
| Long Beach |
| California |
| United States |
| Chicago | Illinois | United States |
| Baltimore | Maryland | United States |
| Minneapolis | Minnesota | United States |
| St Louis | Missouri | United States |
| Albuquerque | New Mexico | United States |
| Santa Fe | New Mexico | United States |
| Armonk | New York | United States |
| Columbus | Ohio | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002294 | Carcinoma, Squamous Cell |
| D018287 | Carcinoma, Large Cell |
| D002277 | Carcinoma |
| 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 |
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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