Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Squamous Cell Carcinoma, Endometrial Transitional Cell Carcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma

In brief

This phase II trial is studying how well brivanib alaninate works in treating patients with endometrial cancer that has come back (recurred) or is persistent. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00888173

Run by

Gynecologic Oncology Group

People needed

45

Starts

2009-07-06

Expected to finish

2016-07-16

Last updated by the study team

2017-12-06

Who can join

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

You may qualify if…

• Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required
• Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell, and transitional cell carcinoma
• All patients must have measurable disease; 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 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 at least one ?target lesion? to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); 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 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 immunologic agents, must be discontinued at least three weeks prior to registration
• Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer will be counted as a systemic chemotherapy regimen
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent endometrial disease according to the following definition:
• Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent endometrial disease, as defined above; however, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
• Patients must NOT have received any non-cytotoxic therapy for management of endometrial cancer with the exception of hormonal therapy
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1
• 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 normal (ULN), CTCAE v3.0 grade 1
• Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 3+ by dipstick (CTCAE v3.0 grade 2 or less); if the urine dipstick is > 3+, 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 (CTCAE v3.0 grade 2 or less)
• Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
• Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
• Albumin greater than or equal to 2.5 g/dl
• Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

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 as noted below, 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 endometrial 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 endometrial 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 CTCAE grade >= 3 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:
• Myocardial infarction within 12 months
• Uncontrolled angina within 12 months
• Class III-IV New York Heart Association (NYHA) congestive heart failure
• Uncontrolled hypertension (systolic blood pressure [BP] > 150 or diastolic BP > 100 mmHg for 24 hours) despite optimized anti-hypertensive therapy; BP must be below 150/100 mmHg 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 ventricle ejection fraction (LVEF) testing and have an ejection fraction > 50%
• Patients with valvular heart disease >= CTCAE grade2
• 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 can not 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
• Patients with known brain metastases
• Patients who are pregnant or nursing
• Patients with inability to swallow tablets or untreated malabsorption syndrome
• Baseline serum potassium < 3.5 mmol/L (potassium supplementation may be given to restore the serum potassium above this level prior to entry study)
• Patients on therapeutic warfarin anticoagulation will be excluded; patients converted to anticoagulation with a heparin compound will be allowed provided the patient?s PT is such that international normalized ratio (INR) is =< 1.5 x ULN

Where it is running

• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• McFarland Clinic PC-William R Bliss Cancer Center — Ames, Iowa, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Iowa-Wide Oncology Research Coalition NCORP — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Laurel — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Iowa Lutheran Hospital — Des Moines, Iowa, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• North Shore University Hospital — Manhasset, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• North Shore-LIJ Health System/Center for Advanced Medicine — New Hyde Park, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oklahoma Cancer Specialists and Research Institute-Tulsa — Tulsa, Oklahoma, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• Carilion Clinic Gynecological Oncology — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.