Overview

This trial is active, not recruiting.

Conditions fallopian tube cancer, primary peritoneal cavity cancer, recurrent borderline ovarian surface epithelial-stromal tumor, recurrent ovarian epithelial cancer, stage iii borderline ovarian surface epithelial-stromal tumor, stage iii ovarian epithelial cancer, stage iv borderline ovarian surface epithelial-stromal tumor, stage iv ovarian epithelial cancer
Treatment belinostat
Phase phase 2
Target HDAC
Sponsor National Cancer Institute (NCI)
Start date September 2006
End date August 2009
Trial size 65 participants
Trial identifier NCT00301756, CDR0000459798, N01CM62203, NCI-2009-00144, NCI-7267, PHL-041, PMH-PHL-041

Summary

This phase II trial is studying how well belinostat works in treating patients with advanced ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat PXD101
Given IV

Primary Outcomes

Measure
Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
time frame: Up to 5 years

Secondary Outcomes

Measure
Time to disease progression
time frame: Up to 5 years
Duration of CA-125 response
time frame: Up to 5 years
Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
time frame: Up to 5 years
Duration of response
time frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Progression-free survival
time frame: Duration of time from start of treatment to time of progression, assessed up to 5 years
Overall Survival
time frame: Up to 5 years
Safety and tolerability of belinostat in patients with platinum resistant and micropapillary/ borderline ovarian tumors
time frame: Up to 5 years
Relationship between clinical and pharmacodynamic effects of belinostat in patients with platinum resistant and micropapillary/ borderline ovarian tumors
time frame: Up to 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of 1 of the following: - Micropapillary or borderline (low malignant potential) ovarian tumors - No more than 3 prior chemotherapy regimens - Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer - Recurrent or persistent disease despite initial platinum-based chemotherapy (i.e., platinum-resistant disease) - Disease progression within 6 months after completion of chemotherapy - Received 1-3 prior chemotherapy regimens - At least 1 regimen must have included a platinum agent (carboplatin or cisplatin) - Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan - Measurable disease outside the field of prior radiotherapy OR disease progression after completion of radiotherapy - No known brain metastases - ECOG performance status (PS) ≤ 2 OR Karnofsky PS ≥ 60% - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Bilirubin normal - AST and ALT ≤ 2.5 times upper limit of normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - Not pregnant or nursing - Fertile patients must use effective contraception - No history of allergic reactions attributed to sulfonamides, arginine, and compounds of similar chemical or biological composition to PXD101 - No uncontrolled intercurrent illness, including, but not limited to, any of the following: - Ongoing or active infection - Psychiatric illness or social situation that would limit compliance with study requirements - No bowel obstruction unless receiving parenteral support - No marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 500 msec) - No long-QT syndrome - No significant cardiovascular disease, including any of the following: - Unstable angina pectoris - Uncontrolled hypertension - Congestive heart failure related to primary cardiac disease - Any condition requiring anti-arrhythmic therapy - Ischemic or severe valvular heart disease - Myocardial infarction within the past 6 months - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered - At least 4 weeks since prior radiotherapy or surgery and recovered - No prior radiotherapy to > 40% of bone marrow - At least 2 weeks since prior valproic acid - No concurrent medication that may cause torsades de pointes, including any of the following: - Disopyramide - Dofetilide - Ibutilide - Procainamide - Quinidine - Sotalol - Bepridil - Amiodarone - Arsenic trioxide - Cisapride - Methadone - Lidoflazine - Clarithromycin - Erythromycin - Halofantrine - Pentamidine - Sparfloxacin - Domperidone - Droperidol - Chlorpromazine - Haloperidol - Mesoridazine - Thioridazine - Pimozide - No other concurrent anticancer therapy - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients

Additional Information

Official title A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors
Principal investigator Amit Oza
Description PRIMARY OBJECTIVES: I. To determine the antitumor activity of PXD 101 as a single agent in the following patient population using objective response rates (complete and partial): a) Platinum resistant ovarian carcinoma (progression within 6 months of platinum based therapy); b) Micropapillary / borderline (Low Malignant potential) ovarian carcinoma. SECONDARY OBJECTIVES: I. To determine the antitumor activity of PXD 101 with regards to stable disease rates, duration of response, progression- free, median and overall survival rates as well as determine the safety and tolerability this drug. TERTIARY OBJECTIVES: I. To determine the relationship between clinical and pharmacodynamic effects of PXD101 in patients with platinum resistant and micropapillary tumors undergoing treatment with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (micropapillary or borderline ovarian tumor vs platinum-resistant ovarian epithelial, primary peritoneal, or fallopian tube cancer). Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).