Trial Outcomes & Findings for Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery (NCT NCT00268450)

NCT ID: NCT00268450

Last Updated: 2018-07-12

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

From day of first treatment until after cycle 3

Results posted on

2018-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Study Intervention Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin. bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles cysectomy
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Intervention n=21 Participants Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin. bevacizumab: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles cysectomy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 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	2 Participants n=5 Participants
Race (NIH/OMB) White	19 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	21 participants n=5 Participants

PRIMARY outcome

Timeframe: From day of first treatment until after cycle 3

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 6 and week 12

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and week 12

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from first treatment until time of progression or death, whichever comes first

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from first treatment until death

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from first treatment until end of week 12

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from first treatment until up to 48 hours after surgery.

Population: Data for this outcome measure was not collected

Outcome measures

Outcome data not reported

Adverse Events

Study Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kate Anderton

Medical University of South Carolina

Phone: 843-792-2708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place