Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
7 other identifiers
interventional
44
1 country
5
Brief Summary
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2004
Longer than P75 for phase_2
5 active sites
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
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 13, 2012
CompletedFebruary 8, 2022
January 1, 2022
6.7 years
November 9, 2004
November 8, 2012
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
after 6 weeks (2 cycles)
Secondary Outcomes (2)
Evaluate the Progression-free Survival Rate
up to 85 months of follow-up
Overall Survival
up to 85 months of follow-up
Study Arms (2)
Arm I (closed to accrual 10/10/2008)
EXPERIMENTALPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
Arm II
EXPERIMENTALPatients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given orally
Eligibility Criteria
You may qualify if:
- Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Recurrent disease
- Must have received a prior platinum-based regimen
- Platinum-sensitive (treatment-free interval \> 6 months)
- No more than 2 prior chemotherapy regimens
- Measurable disease
- At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- Not in a prior irradiation field
- No known brain metastases
- Performance status:
- ECOG 0-2 OR
- Karnofsky 80-100%
- Life expectancy:
- More than 12 weeks
- Hematopoietic:
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Moffitt Cancer Center at Tampa General Hospital
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Waggoner, MD
- Organization
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Waggoner
Case Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 9, 2004
Study Start
August 1, 2004
Primary Completion
April 21, 2011
Study Completion
August 1, 2011
Last Updated
February 8, 2022
Results First Posted
December 13, 2012
Record last verified: 2022-01