Status:
COMPLETED
3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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. Th...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer. II. Determi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
- Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No serious cardiac disease
- No prior myocardial infarction
- No uncontrolled congestive heart failure
- No pulmonary disease requiring oxygen
- 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
- 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
- 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
- At least 1 week since prior hormonal therapy for malignant tumor
- Concurrent hormone replacement therapy allowed
- No prior radiotherapy to more than 25% of marrow-bearing areas
- Recovered from prior radiotherapy
- Recovered from prior surgery
- No prior cancer therapy that contraindicates receiving study therapy
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00081276
Start Date
July 1 2005
Last Update
January 24 2013
Active Locations (1)
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1
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103