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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

Phase 2
18 Years
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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Trial Information

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


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.


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.

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Time at risk will be assessed from the date of registration onto the study and include all eligible patients who receive any study treatment. An analysis of any potential treatment effect on PFS may be conducted against the historical controls provided in GOG 126 and GOG 146 using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Susan Modesitt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

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



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103