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

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vorinostat
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vorinostat)

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
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

Secondary Outcome Measures

Clinical response (partial and complete response) rate as according to RECIST s
Duration of PFS
Duration of survival

Full Information

First Posted
August 16, 2005
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00132067
Brief Title
Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Official Title
A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852]) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vorinostat)
Arm Type
Experimental
Arm Description
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
vorinostat
Other Intervention Name(s)
L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
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.
Time Frame
At 6 months
Title
Toxicity as assessed by CTCAE v 3.0
Time Frame
Up to 5 years after completion of study treatment
Secondary Outcome Measure Information:
Title
Clinical response (partial and complete response) rate as according to RECIST s
Time Frame
Up to 5 years
Title
Duration of PFS
Time Frame
From study entry until disease progression, death or date of last contact., assessed up to 5 years
Title
Duration of survival
Time Frame
From entry into the study to death or the date of last contact, assessed up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Modesitt
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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

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