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

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.