3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer

NCT ID: NCT00081276

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

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. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer

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. 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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (triapine and cisplatin)

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.

Group Type: EXPERIMENTAL

triapine

Intervention Type: DRUG

Given IV

cisplatin

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

triapine

Given IV

Intervention Type: DRUG

cisplatin

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

3-AP; OCX-191; CACP; CDDP; CPDD; DDP

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lydia Usha

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

References

Kunos C, Radivoyevitch T, Abdul-Karim FW, Fanning J, Abulafia O, Bonebrake AJ, Usha L. Ribonucleotide reductase inhibition restores platinum-sensitivity in platinum-resistant ovarian cancer: a Gynecologic Oncology Group Study. J Transl Med. 2012 Apr 27;10:79. doi: 10.1186/1479-5876-10-79.

Reference Type: DERIVED

PMID: 22541066 (View on PubMed)

Other Identifiers

GOG-0126O

Identifier Type: -

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000360854

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02585

Identifier Type: -

Identifier Source: org_study_id