Dalantercept 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 studies how well dalantercept works in treating patients with endometrial cancer that has come back or is persistent. Dalantercept may stop the growth of endometrial cancer by blocking blood flow to the tumor.

Key facts

Study ID

NCT01642082

Run by

Gynecologic Oncology Group

People needed

28

Starts

2012-09-01

Expected to finish

2016-01-01

Last updated by the study team

2018-03-13

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; 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 carcinoma, and transitional cell carcinoma
• All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) 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 version 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 investigational drug must be discontinued at least 30 days prior to registration
• Any prior radiation therapy must be discontinued at least four weeks prior to registration
• At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)
• Prior therapy
• Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; 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 disease
• Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease; prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment; prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
• Platelets greater than or equal to 100,000/mcL
• Hemoglobin greater than or equal to 9 g/dL
• Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)
• Sodium greater than or equal to 130 mEq/L (Common Terminology Criteria for Adverse Events [CTCAE] v. 4, grade 0 or 1)
• Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1,000 mg (< 1.0 g/24 hrs) for patient enrollment
• Bilirubin less than or equal to 1.5 times ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times ULN
• Alkaline phosphatase less than or equal to 3 times ULN

You may not qualify if…

• Patients who have had prior therapy with dalantercept or other inhibitor of the ALK1 pathway
• 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 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 with history or evidence upon physical exam of central nervous system disease (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases or leptomeningeal disease
• Serious or non-healing wound, ulcer, or bone fracture
• History of abdominal fistula or anastomotic leak, gastrointestinal perforation, or intra-abdominal abscess within 6 months of registration
• Patients requiring parenteral hydration or parenteral/total parenteral nutrition
• No patients with:
• Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to ½ teaspoon [2.5 ml] in any 24-hour period) within 2 weeks prior to registration or gastrointestinal bleeding within 3 months prior to registration
• Hereditary hemorrhagic telangiectasia (HHT)
• Platelet function abnormality
• Autoimmune or hereditary hemolysis
• Coagulopathy, or
• Tumor involving major vessels (defined as any lesion invading or abutting the wall [i.e., no fat plane evident] of major blood vessels as assessed by CT or MRI)
• Patients receiving treatment with full-dose aspirin (325 mg oral daily), clopidogrel (Plavix), or dabigatran (Pradaxa)
• Patients with peripheral edema greater than or equal to grade 1 within 4 weeks of registration
• No patients with clinically significant cardiovascular disease:
• Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications
• Evidence of hypertrophic cardiomyopathy
• New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
• Any of the following within 6 months prior to study registration:
• Bypass surgery
• Stent placement
• Myocardial infarction

Where it is running

• UCSF Medical Center-Mount Zion — San Francisco, California, 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
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Maine Medical Center-Bramhall Campus — Portland, Maine, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
• Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Cleveland Clinic Cancer Center/Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Hillcrest Hospital Cancer Center — Mayfield Heights, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Sanford Cancer Center-Oncology Clinic — Sioux Falls, South Dakota, United States
• Sanford NCI Community Oncology Research Program of the North Central Plains — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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