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The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 40 to 80 mg/m^2 by dose escalations in 10 mg/m2 increments if no dose-limiting toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | Every 8 weeks until progression. | |
| Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria. | Every 8 weeks until progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: HRPC Cohort: confirmed response rate according to RECIST; progression-free survival (PFS) for progression according to RECIST; new bone lesions or skeletal events; PFS according to PSA progression; overall survival. | Every 8 weeks until progression. | |
| Efficacy: HCC cohort - PFS (RECIST); overall survival |
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Inclusion Criteria:
Exclusion Criteria:
Please note: There are additional criteria that must be met in order to be eligible for this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | France | |||||
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C102714 | irofulven |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Irofulven | Drug | Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered as a 30-minute infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 0.30 to 0.40 mg/kg if no dose-limiting toxicity. |
|
| Every 8 weeks until progression. |
| Clichy |
| France |
| Lyon | France |
| Nice | France |
| Paris | France |
| Poitiers | France |
| Saint-Cloud | France |
| D008107 |
| Liver Diseases |