A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
triapine
+ cisplatin
+ laboratory biomarker analysis
Carcinoma, Ovarian Epithelial+19
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: July 1, 2005
Actual date on which the first participant was enrolled.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. Determine the toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival in patients treated with this regimen. II. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location