Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)
6 other identifiers
interventional
31
1 country
43
Brief Summary
This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or 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 Apr 2011
Typical duration for phase_2
43 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
First Submitted
Initial submission to the registry
December 24, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedStudy Start
First participant enrolled
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2014
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedMarch 20, 2019
March 1, 2019
2.9 years
December 24, 2010
November 4, 2016
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Objective Tumor Response
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1
Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.
Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.
Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease
Adverse Events (Grade 3 or Higher) During Treatment Period
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0
During treatment period and up to 30 days after stopping the study treatment.
Secondary Outcomes (2)
Progression-free Survival
From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up
Overall Survival
From study entry to time of death or the date of last contact, up to 5 years of follow-up.
Other Outcomes (1)
Serum Expression Levels of Surrogate Markers of Brivanib Alaninate Effects Including Angiogenic Factors (VEGF and bFGF) and Markers of Endothelial Damage (E-selectin, VCAM-1, and ICAM-1)
Up to 5 years
Study Arms (1)
Treatment (brivanib alaninate)
EXPERIMENTALPatients receive brivanib alaninate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma, or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
- All patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
- Patient must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1
- Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
- In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
- Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
- Patients who have received two prior regimens must have a GOG performance status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration
- Any prior radiation therapy must be completed at least 4 weeks prior to registration
- At least 4 weeks must have elapsed from the time of any major surgical procedure
- Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix; chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
- +20 more criteria
You may not qualify if:
- Patients who have had prior therapy with brivanib or anti-vascular, anti-PDGFR (platelet-derived growth factor receptor) or anti-FGFR (fibroblast growth factor receptor) therapy
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded
- Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded
- Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients that are on required chronic anti-platelet therapy (aspirin \> 300 mg/day, or clopidogrel greater than or equal to 75 mg/day)
- Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event \>= grade 3 of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) within 30 days prior to study entry
- Patients with a history of poor wound healing, non-healing ulcers, or bone fractures within the last 3 months
- Patients with uncontrolled or significant cardiovascular disease including any of the following:
- Myocardial infarction within 12 months
- Uncontrolled angina within 12 months
- Class III-IV New York Heart Association (NYHA) congestive heart failure
- Uncontrolled hypertension despite anti-hypertensive therapy
- Blood pressure (BP) must be less than or equal to 140/90 at screening
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (43)
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
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
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Publications (1)
Chan JK, Deng W, Higgins RV, Tewari KS, Bonebrake AJ, Hicks M, Gaillard S, Ramirez PT, Chafe W, Monk BJ, Aghajanian C. A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 Sep;146(3):554-559. doi: 10.1016/j.ygyno.2017.05.033. Epub 2017 Jul 18.
PMID: 28728751DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Wei Deng,PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
John K Chan
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2010
First Posted
December 28, 2010
Study Start
April 4, 2011
Primary Completion
February 28, 2014
Study Completion
February 28, 2014
Last Updated
March 20, 2019
Results First Posted
January 4, 2017
Record last verified: 2019-03