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

Primary Peritoneal Cavity Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081276
• Other study ID #: NCI-2012-02585
• Secondary ID: GOG-0126OU10CA02
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: January 23, 2013
• Start date: July 2005

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• triapine
Given IV
• cisplatin
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and duration of objective response assessed using RECIST criteria		Up to 5 years	No
Primary	Frequency and severity of observed adverse effects assessed using CTCAE version 3.0		Up to 5 years	Yes
Secondary	Duration of progression-free survival		From study entry until disease recurrence, death or date of last contact, assessed up to 5 years	No
Secondary	Duration of overall survival		From study entry to death or date of last contact, assessed up to 5 years	No
Secondary	Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)		Up to 5 years	No