3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer

• Frequency and duration of objective response [ Designated as safety issue: No ]
• Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

• Frequency and duration of objective response
• Frequency and severity of observed adverse effects

• Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
• Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology) [ Designated as safety issue: No ]

• Duration of progression-free survival and overall survival
• Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)

RATIONALE: Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer.

OBJECTIVES:

Primary

• Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
• Determine the toxicity of this regimen in these patients.

Secondary

• Determine the duration of progression-free survival and overall survival in patients treated with this regimen.
• Determine the effects of prognostic variables, including initial performance status, age, and mucinous (or clear cell) histology, in these patients.

OUTLINE: This is a non-randomized study.

Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13 months.

• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

• Drug: cisplatin
• Drug: triapine

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal cancer

  • Recurrent or persistent disease

• At least 1 unidimensionally measurable target lesion

  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Outside a previously irradiated field

• Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease

  • Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment

• Considered platinum resistant or refractory, according to 1 of the following criteria:

  • Treatment-free interval of less than 6 months after platinum-based therapy
  • Disease progression during platinum-based therapy
• Ineligible for any higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2 (for patients who received 1 prior treatment regimen)
• GOG 0-1 (for patients who received 2 prior treatment regimens)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No serious cardiac disease
• No prior myocardial infarction
• No uncontrolled congestive heart failure

Pulmonary

• No pulmonary disease requiring oxygen

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Neuropathy (sensory and motor) ≤ grade 1
• No active infections requiring antibiotics
• No hearing impairment
• No known G6PD deficiency
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior biologic or immunologic agents for malignant tumor
• One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed

Chemotherapy

• See Disease Characteristics
• One prior paclitaxel-containing regimen allowed
• No prior 3-AP
• No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
• Recovered from prior chemotherapy

Endocrine therapy

• At least 1 week since prior hormonal therapy for malignant tumor
• Concurrent hormone replacement therapy allowed

Radiotherapy

• No prior radiotherapy to more than 25% of marrow-bearing areas
• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• No prior cancer therapy that contraindicates receiving study therapy