Completed

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

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What is being tested

triapine

+ cisplatin

+ laboratory biomarker analysis

DrugOther
Who is being recruted

Carcinoma, Ovarian Epithelial+19

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2005
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA 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 
NCT00081276
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsPathologic ProcessesRecurrenceUrogenital NeoplasmsDisease AttributesFemale Urogenital Diseases

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study 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

Suspended

Gynecologic Oncology Group

Philadelphia, United StatesSee the location
CompletedOne Study Center