A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer
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