Trial Outcomes & Findings for Vorinostat in Treating Patients With Kidney Cancer (NCT NCT00278395)

Results Overview

Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

1 year

Results posted on

2017-11-14

Participant Flow

Open to recruitment on 12/5/2005, closed to recruitment on 3/3/09 at The University of Texas Health Science Center San Antonio at Cancer and Therapy Research Center

Participant milestones

Participant milestones
Measure	Vorinostat The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vorinostat The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
Overall Study Adverse Event	2
Overall Study Nonevaluable	1

Baseline Characteristics

Vorinostat in Treating Patients With Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat n=14 Participants The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The overall duration of response will be estimated using the Kaplan-Meier method for all patients who presented with an objective response.

Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - 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.

Outcome measures

Outcome measures
Measure	Vorinostat n=11 Participants The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
Objective Response Best Objective Response Rate (ORR)	4 participants
Objective Response Progressive Disease	7 participants

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Vorinostat

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vorinostat n=14 participants at risk The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	7.1% 1/14 • Number of events 1
Cardiac disorders Congestive Heart Failure	7.1% 1/14 • Number of events 1

Other adverse events

Other adverse events
Measure	Vorinostat n=14 participants at risk The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
Gastrointestinal disorders Nausea	50.0% 7/14 • Number of events 7
Blood and lymphatic system disorders Fatigue	50.0% 7/14 • Number of events 7
Gastrointestinal disorders Weight loss	42.9% 6/14 • Number of events 6
Gastrointestinal disorders Diarrhea	28.6% 4/14 • Number of events 4
Gastrointestinal disorders Vomiting	28.6% 4/14 • Number of events 4

Additional Information

Dr. John Sarantopoulos

University of Texas Health Science Center at San Antonio

Phone: 210-450-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60