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

NCT ID: NCT00374660

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-04-30

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.

Conditions

Liver Cancer

Keywords

Irofulven; Oxaliplatin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: 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.

Irofulven

Intervention Type: 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.

Interventions

Oxaliplatin

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.

Intervention Type: DRUG

Irofulven

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.

2. Malignant solid tumor confirmed by a biopsy sample.

3. Pancreatic, endometrial, gastric, and hepatocellular cancer patients that have exhausted standard treatment options.

4. Measurable disease according to RECIST.

5. 18 years of age or older.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-1.

7. Life expectancy greater than 3 months.

8. 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).

9. Patients of reproductive age must be using effective contraceptive methods.

10. Negative pregnancy test for patients of reproductive potential.

Exclusion Criteria

1. Prior therapy with irofulven or oxaliplatin.

2. Patients who have had radiation therapy to more than 30% of the bone marrow prior to entry into the study.

3. 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.

4. Presence of any serious concomitant systemic disorders incompatible with the study (e.g., uncontrolled congestive heart failure, active infection).

5. 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.

6. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.

7. Pregnant or lactating patients or any patient with childbearing potential not using adequate contraception.

8. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bordeaux, , France

Clichy, , France

Lyon, , France

Nice, , France

Paris, , France

Poitiers, , France

Saint-Cloud, , France

Countries

France

Other Identifiers

IROF-017

Identifier Type: -

Identifier Source: org_study_id