Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

Thank you

Trial Information

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


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.


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

Patients are followed for 5 years.

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response assessed using RECIST criteria

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Lydia Usha

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103