Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

Eisai Inc.0 sites63 target enrollmentJune 2003

ConditionsLiver Cancer

InterventionsOxaliplatin Irofulven

Overview

Phase: Phase 1
Intervention: Oxaliplatin
Conditions: Liver Cancer
Sponsor: Eisai Inc.
Enrollment: 63
Primary Endpoint: Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

April 2007

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

Arms & Interventions

1

Intervention: Oxaliplatin

1

Intervention: Irofulven

Outcomes

Primary Outcomes

Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria.

Time Frame: Every 8 weeks until progression.

Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Time Frame: Every 8 weeks until progression.

Secondary Outcomes

Efficacy: HCC cohort - PFS (RECIST); overall survival(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.(Every 8 weeks until progression.)