Trial Outcomes & Findings for Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma (NCT NCT00461851)

Last Updated: 2017-12-14

Results Overview

The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Upon completion of study

Results posted on

2017-12-14

Participant Flow

19 patients were screened, 17 enrolled in the study.

Participant milestones

Participant milestones
Measure	Chemotherapy Plus Sorafenib Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy Plus Sorafenib n=17 Participants Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
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	8 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon completion of study

The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.

Outcome measures

Outcome measures
Measure	Chemotherapy Plus Sorafenib n=17 Participants Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Progression Free Survival (PFS)	9.5 months Interval 5.6 to 16.4

SECONDARY outcome

Timeframe: Upon completion of study

Population: 17 patients were evaluable for toxicity. A total of 77 cycles of gemcitabine/carboplatin were administered with a median 4.5 cycles per patient.

To determine the toxicity of combination therapy with sorafenib, gemcitabine and carboplatin, dose reductions by drug are reported. The number of patients that were reduced in dosage are reported here.

Outcome measures

Outcome measures
Measure	Chemotherapy Plus Sorafenib n=17 Participants Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Dose Ruction (Toxicity) Dose Reduction: Gemcitabine	15 Participants
Dose Ruction (Toxicity) Dose Reduction: Carboplatin	5 Participants
Dose Ruction (Toxicity) Dose Reduction: Sorafenib	9 Participants

SECONDARY outcome

Timeframe: Upon completion of study

The best reported response captures the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin.

Outcome measures

Outcome measures
Measure	Chemotherapy Plus Sorafenib n=17 Participants Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Best Reported Response Partial Response	5 Participants
Best Reported Response Complete Response	4 Participants
Best Reported Response Stable Disease	7 Participants
Best Reported Response Lost to Follow Up	1 Participants

Adverse Events

Chemotherapy Plus Sorafenib

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy Plus Sorafenib n=17 participants at risk Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. Carboplatin: Carboplatin will be given on day 1 to an AUC of 5. Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Infections and infestations Hospitalization for sepsis	5.9% 1/17 • Number of events 1
Cardiac disorders MI	11.8% 2/17 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr Michael Hurwitz

Yale University Yale Cancer Center

Phone: 2037371600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place