Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00374660

First received: September 8, 2006

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2006
Last Updated Date	March 8, 2012
Start Date ^ICMJE	June 2003
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2009)	Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria. [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ] Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria. [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 8, 2006)	Hepatocellular (HCC) cohort - RECIST Confirmed response rate
Change History	Complete list of historical versions of study NCT00374660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2009)	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. ] [ Designated as safety issue: No ] Efficacy: HCC cohort - PFS (RECIST); overall survival [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 8, 2006)	Efficacy HCC cohort - PFS (RECIST), overall survival
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
Official Title ^ICMJE	Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Liver Cancer
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 1 Intervention: Drug: Irofulven + oxaliplatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	63
Completion Date	Not Provided
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed informed consent obtained prior to initiation of any study-specific procedures and treatment. Malignant solid tumor confirmed by a biopsy sample. Pancreatic, endometrial, gastric, and hepatocellular cancer patients that have exhausted standard treatment options. Measurable disease according to RECIST. 18 years of age or older. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-1. Life expectancy greater than 3 months. Previous anticancer treatment must be discontinued at least 4 weeks prior to first dose of study treatment (6 weeks for mitomycin C, 8 weeks for bicalutamide). Patients of reproductive age must be using effective contraceptive methods. Negative pregnancy test for patients of reproductive potential. Exclusion Criteria: Prior therapy with irofulven or oxaliplatin. Patients who have had radiation therapy to more than 30% of the bone marrow prior to entry into the study. Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC > 6), prior mitomycin C cumulative dose greater than or equal to 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support. Presence of any serious concomitant systemic disorders incompatible with the study (e.g., uncontrolled congestive heart failure, active infection). Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry, unless the active malignancy can be unmistakably identified by evidence such as recent biopsies or tumor specific markers. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry. Pregnant or lactating patients or any patient with childbearing potential not using adequate contraception. Patients with retinopathy or significant visual impairment not correctable by refractory lens will be enrolled on a case by case basis according to the expected benefit ratio, taking into account the malignant disease and the existence of an objective decreased visual acuity and its degree. Please note: There are additional criteria that must be met in order to be eligible for this study.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00374660
Other Study ID Numbers ^ICMJE	IROF-017
Has Data Monitoring Committee	Not Provided
Responsible Party	Eisai Inc.
Study Sponsor ^ICMJE	Eisai Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Eisai Inc.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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