Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary
5 other identifiers
interventional
36
1 country
36
Brief Summary
This phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
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 Sep 2008
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 8, 2008
CompletedStudy Start
First participant enrolled
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2013
CompletedResults Posted
Study results publicly available
June 10, 2015
CompletedJuly 23, 2019
July 1, 2019
4.4 years
September 5, 2008
May 27, 2015
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Secondary Outcomes (3)
Progression-free Survival
Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Overall Survival
From study entry to death or last contact, up to 5 years.
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Up to 5 years
Study Arms (1)
Treatment (bevacizumab)
EXPERIMENTALPatients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Patients diagnosed with histologically confirmed recurrent ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules)
- Patients must have measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each ?target? lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT
- Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
- Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
- Patients who have met the pre-entry requirements specified
- There are no restrictions on prior therapy; however, patients cannot have previously had treatment with bevacizumab
- Absolute neutrophil count (ANC) \>= 1,000/?l
- Platelets greater than or equal to 75,000/?l
- Creatinine =\< 1.5 x institutional upper limit normal (ULN)
- Bilirubin =\< 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) less 2.5 x ULN
- Alkaline phosphatase less 2.5 x ULN
- Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1
- Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) \< 1.2 times the upper limit of normal
- +1 more criteria
You may not qualify if:
- Patients with newly diagnosed disease
- Patients with serious non-healing wound, ulcer, or bone fracture
- Patients who have received prior therapy with bevacizumab or other inhibitors of vascular endothelial growth factor (VEGF)
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
- Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
- Patients with clinically significant cardiovascular disease; this includes:
- Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg
- Myocardial infarction or unstable angina within 6 months prior to registration
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Serious cardiac arrhythmic requiring medication.
- Grade 2 or greater peripheral vascular disease
- Patients with GOG performance grade of 3 or 4
- Patients with clinically significant peripheral arterial disease; e.g., claudication within 6 months
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically; a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR \< 1.0 to allow participation in the study
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (36)
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela M. Kuras, Associate Director of Data Management
- Organization
- NRG Oncology Statistics and Data Management Center - Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Jubilee Brown
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- 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
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 8, 2008
Study Start
September 22, 2008
Primary Completion
January 31, 2013
Study Completion
January 31, 2013
Last Updated
July 23, 2019
Results First Posted
June 10, 2015
Record last verified: 2019-07