Trial Outcomes & Findings for Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma (NCT NCT00976183)

Results Overview

Clinical response was assessed by clinical, serologic, and radiographic means.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

2 years or 24 months

Results posted on

2017-04-10

Participant Flow

The recruitment was from one location a private practice. The enrollment started on 01/15/2010. The recruitment was to be a two year time period.

Participant milestones

Participant milestones
Measure	Vorinostat All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat n=18 Participants All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years or 24 months

Population: Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

Clinical response was assessed by clinical, serologic, and radiographic means.

Outcome measures

Outcome measures
Measure	Vorinostat n=18 Participants All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Objective Response Rate	12 participants

SECONDARY outcome

Timeframe: 2 years or 24 months

Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression

Outcome measures

Outcome measures
Measure	Vorinostat n=18 Participants All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Number of Participants With Progression Free Survival (PFS) up to 24 Months	18 participants

Adverse Events

Vorinostat

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vorinostat n=18 participants at risk All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Gastrointestinal disorders gastrointestinal event	16.7% 3/18 • Number of events 3

Other adverse events

Other adverse events
Measure	Vorinostat n=18 participants at risk All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin. Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3. Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 1/18 • Number of events 1
Blood and lymphatic system disorders Neutropenia	11.1% 2/18 • Number of events 2
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1
Nervous system disorders Neuropathy	5.6% 1/18 • Number of events 1

Additional Information

John P. Micha, M.D.

Gynecologic Oncology Associates

Phone: 949-642-5165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place