Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00374660|
Recruitment Status : Unknown
Verified June 2015 by Eisai Inc..
Recruitment status was: Active, not recruiting
First Posted : September 11, 2006
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Irofulven + oxaliplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||August 2007|
Drug: Irofulven + oxaliplatin
Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. Starting dose 40 mg/m^2, dose escalation 50, 60, 70, and 80 mg/m^2 every 28 days if no dose-limiting toxicity.
Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered in a 30-minute infusion on Days 1 and 15 of a 28-day cycle. Starting dose 0.30 mg/kg, dose escalation to 0.40 mg/kg every 28 days if no dose-limiting toxicity.
- Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria. [ Time Frame: Every 8 weeks until progression. ]
- Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria. [ Time Frame: Every 8 weeks until progression. ]
- 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. [ Time Frame: Every 8 weeks until progression. ]
- Efficacy: HCC cohort - PFS (RECIST); overall survival [ Time Frame: Every 8 weeks until progression. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374660
|Saint Cloud, France|