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

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triapine
cisplatin
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (triapine and cisplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency and duration of objective response assessed using RECIST criteria
Frequency and severity of observed adverse effects assessed using CTCAE version 3.0

Secondary Outcome Measures

Duration of progression-free survival
Duration of overall survival
Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)

Full Information

First Posted
April 7, 2004
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081276
Brief Title
3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (triapine and cisplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
triapine
Other Intervention Name(s)
3-AP, OCX-191
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Frequency and duration of objective response assessed using RECIST criteria
Time Frame
Up to 5 years
Title
Frequency and severity of observed adverse effects assessed using CTCAE version 3.0
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Duration of progression-free survival
Time Frame
From study entry until disease recurrence, death or date of last contact, assessed up to 5 years
Title
Duration of overall survival
Time Frame
From study entry to death or date of last contact, assessed up to 5 years
Title
Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Usha
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22541066
Citation
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.
Results Reference
derived

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

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