Trial Outcomes & Findings for Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer (NCT NCT00511992)

NCT ID: NCT00511992

Last Updated: 2017-07-02

Results Overview

Completion of cycle 6

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-07-02

Participant Flow

Participant milestones

Measure	Avastin Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Overall Study STARTED	20
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Baseline characteristics by cohort

Measure	Avastin n=20 Participants Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 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	0 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	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Completion of cycle 6

Outcome measures

Measure	Avastin n=20 Participants Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Number of Patients Able to Complete 6 Cycles of Treatment.	17 Participants

SECONDARY outcome

Timeframe: 2 years

CTCAE assessment of toxicity

Outcome measures

Measure	Avastin n=20 Participants Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.	2 Participants

Adverse Events

Avastin

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Avastin n=20 participants at risk Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Renal and urinary disorders Entero-vesical fistula	5.0% 1/20 • Number of events 1 • 6 years

Other adverse events

Measure	Avastin n=20 participants at risk Avastin: Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
Nervous system disorders Grade 3 Neurpoathy	5.0% 1/20 • Number of events 1 • 6 years
General disorders Grade 3 abdominal pain	5.0% 1/20 • Number of events 1 • 6 years

Additional Information

Ingrid Block, CTO Director

University of Oklahoma

Phone: 405 271-8001

Email: ingrid-block@ouhsc.edu

Results disclosure agreements

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