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: Phase II trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer	Drug: 3-AP  Drug: cisplatin  Procedure: chemotherapy	Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Lydia Usha, MD,  Study Chair,  Rush Cancer Institute at Rush University Medical Center   

Study ID Numbers:  CDR0000360854; GOG-01260
Record last reviewed:  March 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081276
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20