Gamma-Linolenic Acid |
GLA |
Clinical Trial: Suberoylanilide Hydroxamic Acid in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) August 2005
Purpose
RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
| recurrent ovarian epithelial cancer peritoneal cavity cancer | Drug: suberoylanilide hydroxamic acid Procedure: chemotherapy Procedure: enzyme inhibitor therapy | Phase II |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Suberoylanilide Hydroxamic Acid in Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
OBJECTIVES:
Primary
- Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with suberoylanilide hydroxamic acid.
- Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.
Secondary
- Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
- Determine the duration of progression-free survival and overall survival of patients treated with this drug.
- 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 suberoylanilide hydroxamic acid 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.
Eligibility
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, 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
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2 (for patients who received 1 prior treatment regimen) OR
- GOG 0-1 (for patients who received 2 prior treatment regimens)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
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
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 suberoylanilide hydroxamic acid
- No other uncontrolled illness
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
- One additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease allowed
- No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- No prior suberoylanilide hydroxamic acid
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 2 weeks since prior and no concurrent valproic acid
- No prior anticancer therapy that would preclude study participation
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No other concurrent investigational agents
Location and Contact Information
Susan C. Modesitt, MD, Study Chair, University of Kentucky
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: August 18, 2005
Record first received: August 16, 2005
ClinicalTrials.gov Identifier: NCT00132067
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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