Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Completed · Phase 2

Conditions studied: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Serous Adenocarcinoma, Endometrioid Stromal Sarcoma, Recurrent Uterine Corpus Carcinoma

In brief

This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer by blocking blood flow to the tumor.

Key facts

Study ID

NCT01210222

Run by

Gynecologic Oncology Group

People needed

35

Starts

2011-06-06

Expected to finish

2016-07-16

Last updated by the study team

2018-02-23

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; stained slides to document the primary tumor as well as recurrent/persistent disease (if documented by histology or cytology) are 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 carcinoma
• Transitional cell carcinoma
• All patients must have measurable disease as 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
• Patients 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 >= 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 chemotherapy regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior chemotherapy 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
• 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 chemotherapy regimen
• 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
• Prior hormonal therapy is allowed; there is no limit on the number of prior hormonal therapies allowed

You may not qualify if…

• Patients who are currently or have been previously treated with trebananib, or other molecules that inhibit the angiopoietins or Tie2 receptor
• Patient 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 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 who are pregnant or nursing
• Patients with symptoms of partial or complete bowel obstruction; recent (within 6 months) history of fistula, intraabdominal abscess or bowel perforation; subjects requiring total parenteral nutrition or parenteral hydration
• Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases
• Patients with clinically significant cardiovascular disease; this includes:
• Myocardial infarction or unstable angina within 12 months of the first date of study treatment
• New York Heart Association (NYHA) Class II or greater congestive heart failure
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
• Grade 2 or greater peripheral vascular disease
• Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study treatment
• History of arterial ischemia or thrombus
• Patients with uncontrolled hypertension defined as systolic > 150 mm Hg or diastolic > 90 mm Hg; the use of anti-hypertensive medications to control hypertension is permitted
• Patients with significant bleeding within 6 months of enrollment or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
• Patients who have undergone major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of study treatment or who have major surgical procedure anticipated during the course of the study
• Patients who have undergone minor surgical procedures within 7 days of the first date of study treatment
• Paracentesis and thoracentesis are permitted prior to and while on study at the discretion of the investigator and as clinically indicated
• Patients treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment
• Patients with serious non-healing wound, ulcer (including gastrointestinal), or bone fracture
• Patients with known human immunodeficiency virus (HIV), hepatitis C or chronic or active hepatitis B
• Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation
• Patients not available for follow-up assessments
• Patients with known sensitivity to any of the products to be administered during dosing

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Memorial 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 Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Memorial Medical Center — Springfield, 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
• Maine Medical Center-Bramhall Campus — Portland, Maine, 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
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
• Southeast Clinical Oncology Research (SCOR) Consortium NCORP — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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