Trial Outcomes & Findings for Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma (NCT NCT00418093)

Results Overview

Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)

Results posted on

2014-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy Group Oxaliplatin plus Gemcitabine plus Bevacizumab
Overall Study STARTED	19
Overall Study Completed Study	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=19 Participants
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	5 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)

Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria

Outcome measures

Outcome measures
Measure	Chemotherapy Group n=19 Participants Oxaliplatin, Gemcitabine, Bevacizumab
Partial Response Rate	68.4 percentage of patients on study

SECONDARY outcome

Timeframe: Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months

Population: 19

Time participant remains free of progression of her disease. Evaluated by RECIST criteria

Outcome measures

Outcome measures
Measure	Chemotherapy Group n=19 Participants Oxaliplatin, Gemcitabine, Bevacizumab
Progression Free Survival	36.9 weeks Interval 12.0 to 48.0

SECONDARY outcome

Timeframe: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months

Population: All patients enrolled

Duration of time participants are alive after enrolling on the study. Assessed by clinical records

Outcome measures

Outcome measures
Measure	Chemotherapy Group n=19 Participants Oxaliplatin, Gemcitabine, Bevacizumab
Overall Survival	112.3 weeks Interval 90.4 to 136.0

SECONDARY outcome

Timeframe: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial

Population: All patients enrolled

The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported

Outcome measures

Outcome measures
Measure	Chemotherapy Group n=19 Participants Oxaliplatin, Gemcitabine, Bevacizumab
Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.	94.7 percentage of participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=19 participants at risk
Vascular disorders Thrombosis/thrombus/embolism	5.3% 1/19 • Number of events 1

Other adverse events

Other adverse events
Measure	Group 1 n=19 participants at risk
Blood and lymphatic system disorders Neutropenia	31.6% 6/19 • Number of events 6
General disorders Fatigue	36.8% 7/19 • Number of events 7
Nervous system disorders Neuropathy	26.3% 5/19 • Number of events 5
Gastrointestinal disorders Nausea/Vomiting	26.3% 5/19 • Number of events 5
Cardiac disorders Hypertension	10.5% 2/19 • Number of events 2
Immune system disorders Allergic Reaction to Oxaliplatin	5.3% 1/19 • Number of events 1

Additional Information

Neil Horowitz, MD

Dana-Farber Cancer Institute

Phone: 617-732-8843

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place