Trial Outcomes & Findings for Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium (NCT NCT00363883)

Last Updated: 2015-02-13

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Response assessed after every 2 cycles (6 weeks) up to 26 weeks

Results posted on

2015-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Vorinostat) Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vorinostat) n=14 Participants Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Response assessed after every 2 cycles (6 weeks) up to 26 weeks

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=14 Participants Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Objective Tumor Response Rate	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 26 weeks

Will be estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=14 Participants Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Overall Survival	4.3 months Interval 2.1 to 8.3

SECONDARY outcome

Timeframe: assessed up to 26 weeks

Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=14 Participants Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Progression-free Survial	1.1 months Interval 1.0 to 2.1

Adverse Events

Treatment (Vorinostat)

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vorinostat) n=14 participants at risk Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Cardiac disorders Cardiopulmonary arrest	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Sudden death	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Intraoperative urinary injury	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Treatment (Vorinostat) n=14 participants at risk Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin decreased	57.1% 8/14 • Number of events 18 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia supraventricular	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	21.4% 3/14 • Number of events 4 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 6 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	28.6% 4/14 • Number of events 8 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	7.1% 1/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	64.3% 9/14 • Number of events 12 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	35.7% 5/14 • Number of events 8 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	42.9% 6/14 • Number of events 6 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	28.6% 4/14 • Number of events 4 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	78.6% 11/14 • Number of events 24 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bladder infection	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	35.7% 5/14 • Number of events 8 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	35.7% 5/14 • Number of events 8 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	64.3% 9/14 • Number of events 27 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	42.9% 6/14 • Number of events 20 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	28.6% 4/14 • Number of events 6 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	64.3% 9/14 • Number of events 16 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	42.9% 6/14 • Number of events 8 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	21.4% 3/14 • Number of events 7 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	42.9% 6/14 • Number of events 17 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	28.6% 4/14 • Number of events 10 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	7.1% 1/14 • Number of events 5 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	21.4% 3/14 • Number of events 4 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	28.6% 4/14 • Number of events 5 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium increased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	28.6% 4/14 • Number of events 6 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Buttock pain	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	7.1% 1/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ataxia	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	14.3% 2/14 • Number of events 5 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	14.3% 2/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	28.6% 4/14 • Number of events 6 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	35.7% 5/14 • Number of events 7 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	7.1% 1/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60