abstract: A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study

A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study:

Background
Patients with recurrent ovarian cancer have limited options, especially in the context of relapse less than six months from primary platinum-based therapy. This Gynecologic Oncology Group (GOG) study was conducted to evaluate the impact of the histone deacetylase inhibitor, belinostat, in combination with carboplatin in women with platinum-resistant ovarian cancer.

Methods 
Eligible patients had measurable, recurrent disease within six months of their last dose of a platinum-based combination. Belinostat was dosed at 1000mg/m² daily for five days with carboplatin AUC 5 on day three of 21-day cycles. The primary endpoint was overall response rate (ORR), using a two-stage design.

Results
Twenty-nine women enrolled on study and 27 were evaluable. The median number of cycles given was two (range 1–10). One patient had a complete response and one had a partial response, for an ORR of 7.4% (95% CI, .9%–24.3%). Twelve patients had stable disease while eight had increasing disease. Response could not be assessed in five (18.5%). Grade 3 and 4 events occurring in more than 10% of treated patients were uncommon and limited to neutropenia (22.2%), thrombocytopenia (14.8%), and vomiting (11.1%). The median progression-free survival (PFS) was 3.3months and overall survival was 13.7months. PFS of at least six months was noted in 29.6% of patients. Due to the lack of drug activity, the study was closed after the first-stage.

Conclusions 
The addition of belinostat to carboplatin had little activity in a population with platinum-resistant ovarian cancer.

PharmaLive: Topotarget Announces Updates on Belinostat in Two Clinical Trials - NSCLC and Ovarian Cancer (negative study ovarian/Belinostat/Carboplatin)

Ovarian cancer – GOG 0126-T (NCI-driven study)

Preliminary analysis of GOG 0126-T trial has not shown enough activity to enter into second stage. Consequently the study will be ended.

The study

The study is an open-label single-arm phase II trial with belinostat in combination with carboplatin given to patients with ovarian cancer who progress during or shortly after first-line treatment with platinum containing chemotherapy. The trial is sponsored by the GOG with support from the NCI. Belinostat is administered as a 30-minute daily IV infusion on day one through five with carboplatin being administered on day three. Treatment is given every third week and is repeated until disease progression......