Trial Outcomes & Findings for Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma (NCT NCT00714948)

NCT ID: NCT00714948

Last Updated: 2015-11-16

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: conclusion of the study
• Results posted on: 2015-11-16

Participant Flow

Protocol Open to Accrual: 07/10/2008 Protocol Closed to Accrual:12/08/2009 Primary Completion Date: 11/22/2011 Recruitment Location is the medical clinic

Participant milestones

Measure	Gemcitabine and Split-dose Cisplatin + Sorafenib This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib. Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Gemcitabine and Split-dose Cisplatin + Sorafenib This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib. Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.

Overall Study Adverse Event

2

Baseline Characteristics

Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Gemcitabine and Split-dose Cisplatin + Sorafenib n=2 Participants This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib. Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: conclusion of the study

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine and Split-dose Cisplatin + Sorafenib

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gemcitabine and Split-dose Cisplatin + Sorafenib n=2 participants at risk This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib. Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.
Infections and infestations Bladder infection	50.0% 1/2 • Number of events 1
Surgical and medical procedures Thromboembolic event	50.0% 1/2 • Number of events 1

Other adverse events

Measure	Gemcitabine and Split-dose Cisplatin + Sorafenib n=2 participants at risk This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib. Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 2
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Number of events 10
Investigations Creatinine increased	100.0% 2/2 • Number of events 15
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 3
General disorders Edema: limbs	50.0% 1/2 • Number of events 1
General disorders Fatigue	100.0% 2/2 • Number of events 8
Metabolism and nutrition disorders Hyperglycemia	100.0% 2/2 • Number of events 31
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 23
Renal and urinary disorders Hemorrhage, Urinary NOS	50.0% 1/2 • Number of events 2
Investigations INR increased	50.0% 1/2 • Number of events 5
Investigations White blood cell decreased	100.0% 2/2 • Number of events 7
Metabolism and nutrition disorders Hypomagnesemia	100.0% 2/2 • Number of events 11
Musculoskeletal and connective tissue disorders Generalized muscle weakness	100.0% 2/2 • Number of events 3
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 5
Nervous system disorders Peripheral sensory neuropathy	50.0% 1/2 • Number of events 1
Investigations Neutrophil count decreased	100.0% 2/2 • Number of events 7
Investigations Activated partial thromboplastin time prolonged	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • Number of events 3
Investigations Platelet count decreased	100.0% 2/2 • Number of events 11
Metabolism and nutrition disorders Hyperkalemia	50.0% 1/2 • Number of events 3
Metabolism and nutrition disorders Hypokalemia	100.0% 2/2 • Number of events 7
Skin and subcutaneous tissue disorders Rash/desquamation	50.0% 1/2 • Number of events 1
Skin and subcutaneous tissue disorders Rash: erythema multiforme	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	100.0% 2/2 • Number of events 8
Renal and urinary disorders Urinary frequency	50.0% 1/2 • Number of events 5
Gastrointestinal disorders Vomiting	100.0% 2/2 • Number of events 3
Investigations Weight loss	100.0% 2/2 • Number of events 6

Additional Information

Dr. Dean Bajorin

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4333

Email: bajorind@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place