FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer

NCT00085527 | Withdrawn Phase 2

• 4 other identifiers: 12965AUCCRC-12965LUMC-106995NCI-6347
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Response rate of depsipeptide in ovarian cancer

  8 weeks

Study Arms (1)

depsipeptide

EXPERIMENTAL

Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.

Drug: depsipeptide

Interventions

depsipeptide DRUG

Also known as: Romidepsin, Istodax®

depsipeptide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed ovarian epithelial carcinoma * Advanced disease * Relapsed after OR refractory to 1, and only 1, prior platinum- or taxane-based regimen * Refractory disease defined as disease progression during platinum- or taxane-based therapy * Relapsed disease defined as platinum or taxane resistant or sensitive * Platinum or taxane resistance defined as relapse within 6 months after prior platinum or taxane therapy * Platinum or taxane sensitivity defined as relapse \> 6 months from the last platinum or taxane treatment * Measurable or evaluable disease * Measurable disease defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Evaluable disease determined by elevation in CA 125 (≥ 2 times upper limit of normal \[ULN\]), ascites, or pleural effusion * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 OR * Karnofsky 60-100% Life expectancy * At least 24 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times ULN * Bilirubin normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * QTc \< 500 msec * LVEF \> 40% by MUGA * No significant cardiac disease * No symptomatic congestive heart failure * No unstable or poorly controlled angina pectoris * No uncontrolled dysrhythmias * No New York Heart Association class III or IV congestive heart failure * No myocardial infarction within the past year * No prior serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * No left ventricular hypertrophy by EKG Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Potassium ≥ 4.0 mmol/L * Magnesium ≥ 2.0 mg/dL * No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide) * No concurrent uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic agents Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior FR901228 (depsipeptide) * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * Prior surgical resection allowed Other * No concurrent drugs known to have HDI activity (e.g., sodium valproate) * No concurrent agents that cause QTc prolongation * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent hydrochlorothiazide * No other concurrent investigational agents * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Depsipeptides; romidepsin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gini Fleming, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)