Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

OBJECTIVES:

I. Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at least 6 months.

Inclusion criteria

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

• Recurrent or persistent disease
• At least 1 unidimensionally measurable target lesion* defined as:

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease

• Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel
• Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
• Platinum-sensitive disease

• Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum
• Performance status - GOG 0-2 for patients who received 1 prior therapy regimen
• Performance status - GOG 0-1 for patients who received 2 prior therapy regimens
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No prior congestive heart failure requiring medication
• No uncontrolled hypertension within the past 6 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
• No history of retinopathy and/or macular degeneration
• No neuropathy (sensory and motor) greater than grade 1
• No active infection requiring antibiotics
• No other illness or condition that would preclude study entry
• No prior bone marrow or stem cell transplantation
• At least 3 weeks since prior biologic therapy or immunotherapy for malignant tumor
• One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) allowed
• See Disease Characteristics
• At least 3 weeks since prior chemotherapy and recovered
• No prior irofulven
• No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
• At least 1 week since prior hormonal therapy for malignant tumor
• Concurrent hormone replacement therapy allowed
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas
• Recovered from recent prior surgery
• At least 3 weeks since any other prior therapy for malignant tumor
• No prior anticancer treatment that would preclude study therapy
• One prior noncytotoxic cytostatic regimen for recurrent or persistent disease allowed