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Suberoylanilide Hydroxamic Acid in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer - Article


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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

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00132067

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

Further Study Details: 

OBJECTIVES:

Primary

Secondary

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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, 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

  • 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 suberoylanilide hydroxamic acid
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Radiotherapy

Surgery

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00132067


Study chairs or principal investigators

Susan C. Modesitt, MD,  Study Chair,  University of Kentucky   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000439489; GOG-0170H
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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September 6, 2008



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