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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (vorinostat)	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	At 6 months	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.
Toxicity as assessed by CTCAE v 3.0	Up to 5 years after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
Clinical response (partial and complete response) rate as according to RECIST s	Up to 5 years
Duration of PFS	From study entry until disease progression, death or date of last contact., assessed up to 5 years
Duration of survival	From entry into the study to death or the date of last contact, assessed up to 5 years

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

Recruitment & Eligibility

Study & Design

Trial Locations

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