Study Stopped
Did not meet accrual goals.
Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Phase 2 Study of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
2 other identifiers
interventional
5
1 country
1
Brief Summary
The primary objective is to determine whether the addition of bevacizumab to a regimen of carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 5, 2006
CompletedFirst Posted
Study publicly available on registry
December 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
November 16, 2010
CompletedMarch 8, 2018
February 1, 2018
2.8 years
December 5, 2006
October 14, 2010
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival Rate at 9 Months
This Outcome is measuring the number of particpants who have survived.
9 months
Secondary Outcomes (4)
Response to Treatment (Clinical/Pathological)
12 months
Rate of Decline of CA-125
12 months
To Determine the Degree and Type of Toxicity of This Combined Regimen
weekly
Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy
12 months
Study Arms (1)
I
EXPERIMENTALThis is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.
Interventions
cycle #1 and continuous through entire regimen; treated every 3 weeks
cycle #1 and continuous through entire regimen; treated every 3 weeks
Eligibility Criteria
You may qualify if:
- diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma,
- stage III suboptimal surgery or biopsy,
- stage IV disease
- no prior chemotherapy
You may not qualify if:
- unstable heart conditions
- high blood pressure
- vascular disorders
- bleeding problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- Genentech, Inc.collaborator
Study Sites (1)
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This trial ended early after enrolling only 5 of 100 patients. Due to the small enrollment number and incomplete data set, no data analyses were performed.
Results Point of Contact
- Title
- Paige Dunion
- Organization
- UCHC
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Runowicz, MD
UConn Health
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2006
First Posted
December 6, 2006
Study Start
October 1, 2006
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
March 8, 2018
Results First Posted
November 16, 2010
Record last verified: 2018-02