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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Every 8 weeks until progression.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Liver Cancer
  • Irofulven
  • Oxaliplatin
  • Liver Neoplasms