Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	GOG-0170H NCT00132067

Objectives

Primary

1. Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.
2. Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.

Secondary

1. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
2. Determine the duration of progression-free survival and overall survival of patients treated with this drug.
3. Determine the impact of prognostic variables (e.g., platinum sensitivity, performance status, and cellular histology) in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• 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

   [Note: *Tumors within a previously irradiated field are not considered target lesions unless there has been subsequent disease progression at least 90 days after prior radiotherapy]

• 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

Prior/Concurrent Therapy:

Biologic therapy

• At least 4 weeks since prior immunotherapy for the malignancy

Chemotherapy

• See Disease Characteristics
• 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

Endocrine therapy

• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy for the malignancy and recovered
• No prior radiotherapy to > 25% of bone marrow

Surgery

• At least 4 weeks since prior surgery for the malignancy and recovered

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal

• Able to take oral medication
• No bowel obstruction
• No persistent vomiting
• No parenteral feeding

Other

• 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

Expected Enrollment

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

Outcomes

Progression-free at 6 months
Toxicity as measured by CTCAE v 3.0 at every course

Clinical response rate as measured by RECIST criteria after every 2 courses
Duration of progression-free and overall survival

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.

Modesitt SC, Sill M, Hoffman JS, et al.: A phase II study of vorinostat in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 109 (2): 182-6, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Susan Modesitt, MD, Protocol chair		Ph: 859-323-0233

Registry Information
Official Title		A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852, IND #71976]) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Trial Start Date		2005-07-27
Trial Completion Date		2008-07-20
Registered in ClinicalTrials.gov		NCT00132067
Date Submitted to PDQ		2005-06-30
Information Last Verified		2006-04-06
NCI Grant/Contract Number		CA27469

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