Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Persistent Disease, Recurrent Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT01267253

Run by

Gynecologic Oncology Group

People needed

31

Starts

2011-04-04

Expected to finish

2014-02-28

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
• Patients must have NOT received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease
• Non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
• Platelets greater than or equal to 100,000/mcl
• Hemoglobin >= 9 g/dl
• Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
• Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 2+ by dipstick
• If the urine dipstick is > 2+, a 24-hour protein level can be done, as clinically indicated by the investigator
• The 24-hour protein level must be less than or equal to 3.5 g/24 hours

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
• Subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors should be changed to an alternative antihypertensive medication before study entry
• History of stroke, transient ischemic attack (TIA), or other central nervous system (CNS) ischemic event
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
• Patients must have pre-therapy left ventricular ejection fraction (LVEF) testing and have an ejection fraction >= institutional lower limit of normal (LLN)
• Patients with valvular heart disease >= grade 2
• Patients with a serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Patients with hyponatremia (sodium < 130 mEq/L)
• Patients with active/known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; HIV-positive subjects on combination antiretroviral therapy are ineligible
• Patients with known brain metastases

Where it is running

• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limited-Gynecologic Oncology — Hinsdale, Illinois, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Michigan Cancer Research Consortium NCORP — Ann Arbor, Michigan, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Saint Mary Mercy Hospital — Livonia, Michigan, United States
• Saint Joseph Mercy Oakland — Pontiac, Michigan, United States
• Lake Huron Medical Center — Port Huron, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• CoxHealth South Hospital — Springfield, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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