Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

NCT ID: NCT00132067

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-07-31

Brief Summary

This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.

II. Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.

SECONDARY OBJECTIVES:

I. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.

II. Determine the duration of progression-free survival and overall survival of patients treated with this drug.

III. Determine the impact of prognostic variables (e.g., platinum sensitivity, performance status, and cellular histology) in patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within approximately 1 year.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Study Design

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

Study Groups

Treatment (vorinostat)

Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

Given orally

Interventions

vorinostat

Given orally

Intervention Type: DRUG

Other Intervention Names

L-001079038; SAHA; suberoylanilide hydroxamic acid; Zolinza

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
• Recurrent or persistent disease

• Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease

• Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
• Treatment-free interval after completion of platinum-based chemotherapy must have been < 12 months
• Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
• Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
• No known brain metastases
• Performance status - GOG 0-1
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Able to take oral medication
• No bowel obstruction
• No persistent vomiting
• No parenteral feeding
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
• No neuropathy (sensory and motor) > grade 1
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No active infection requiring antibiotics
• No psychiatric illness or social situation that would preclude study compliance
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat
• No other uncontrolled illness
• At least 4 weeks since prior immunotherapy for the malignancy
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered
• No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen
• No prior vorinostat
• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed
• At least 4 weeks since prior radiotherapy for the malignancy and recovered
• No prior radiotherapy to > 25% of bone marrow
• At least 4 weeks since prior surgery for the malignancy and recovered
• At least 4 weeks since other prior therapy for the malignancy
• At least 30 days since prior and no concurrent valproic acid
• Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding
• No prior anticancer therapy that would preclude study participation
• No concurrent combination anti-retroviral therapy for HIV-positive patients
• No other concurrent investigational agents

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

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Modesitt

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02667

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG 0170H

Identifier Type: -

Identifier Source: secondary_id

CDR0000439489

Identifier Type: -

Identifier Source: secondary_id

GOG-0170H

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0170H

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02667

Identifier Type: -

Identifier Source: org_study_id