Clinical Trial: Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors

Brief Summary: This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

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:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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 of Target Lesions, Taking as Reference the Baseline Sum LD [ Time Frame: Up to 5 years ]

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. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.


Original Primary Outcome:

Current Secondary Outcome:

  • Time to Disease Progression (Epithelial Ovarian Cancer Group) [ Time Frame: Up to 5 years ]
    Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.
  • 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 (Low Malignant Potential Group) [ Time Frame: Up to 5 years ]
    Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.
  • 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 ]
    Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
  • Progression-free Survival [ Time Frame: Duration of time from start of treatment to time of progression, assessed up to 5 years ]
    Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
  • Overall Survival [ Time Frame: Up to 5 years ]
    Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
  • Safety and Tolerability of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors [ Time Frame: Up to 5 years ]
    Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated using counts and proportions detailing frequently occurring, serious and related events of interest.
  • Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group) [ Time Frame: Up to 5 years ]
    Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.
  • 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 (Epithelial Ovarian Cancer Group) [ 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. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 9, 2006
Date Started: September 2006
Date Completion:
Last Updated: October 20, 2016
Last Verified: October 2016