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The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin | Experimental |
| |
| Irinotecan (12 (9) mg/m²/day) | Experimental |
| |
| Irinotecan (10 (10) mg/m²/day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety and tolerability | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment | Every other cycle for 22 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Irinotecan | Drug | IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity |
|
|
| Irinotecan | Drug | IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity |
|
|
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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