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The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motexafin Gadolinium Injection | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin | ||
| Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response |
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Inclusion Criteria:
Exclusion Criteria:
Laboratory values demonstrating inadequate function of the following:
and
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002283 | Carcinoma, Bronchogenic |
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002294 | Carcinoma, Squamous Cell |
| D018287 | Carcinoma, Large Cell |
| ID | Term |
|---|---|
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
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