vorinostat and Peritoneal Neoplasms

vorinostat has been researched along with Peritoneal Neoplasms in 3 studies

Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.
vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL).

Peritoneal Neoplasms: Tumors or cancer of the PERITONEUM.

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Dose Limiting Toxicity (DLT) [Phase Ib]

"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity." (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]

The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Response

Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable. (NCT00910000)
Timeframe: Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).

Trials

3 trials available for vorinostat and Peritoneal Neoplasms