Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma

In brief

This phase II trial studies how well pazopanib hydrochloride works in treating patients with uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to the tumor.

Key facts

Study ID

NCT01247571

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2011-01-01

Expected to finish

2016-01-01

Last updated by the study team

2019-08-08

Who can join

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

You may qualify if…

• Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent; acceptable histological type is defined as carcinosarcoma (malignant mixed müllerian tumor), homologous or heterologous type
• Patients must have measurable disease
• Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 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 greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or greater than or equal to 20 mm when measured by chest x-ray
• Lymph nodes must be greater than or equal to 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 must have a GOG performance status of 0, 1, or 2
• 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 (chemotherapy) directed at the malignant tumor, must be discontinued at least three weeks prior to registration
• At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule - minor: central venous access catheter placement)
• Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; 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 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 disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
• Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is permitted
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
• Platelets greater than or equal to 100,000/mcL
• Hemoglobin level greater than or equal to 9 g/dL
• Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)

You may not qualify if…

• Patients who have had prior therapy with pazopanib
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, 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 uterine carcinosarcoma 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 uterine carcinosarcoma 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 clinically significant cardiovascular disease; this includes:
• Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility
• Myocardial infarction or unstable angina within 6 months of the first date of pazopanib therapy
• 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; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
• Women who have received prior anthracycline (e.g., doxorubicin and/or liposomal doxorubicin) and who have an ejection fraction less than the institutional lower limit of normal will be excluded from the study; patients with a prior life time exposure to doxorubicin (or liposomal doxorubicin) of greater than 300 mg/m\^2 are NOT eligible
• CTCAE grade 2 or greater peripheral vascular disease
• History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of pazopanib therapy
• Women with a baseline QTc >= 480 milliseconds
• History of cardiac angioplasty or stenting within 6 months prior to registration; history of coronary artery bypass graft surgery within 6 months prior to registration
• A patient with arterial thrombosis within 6 months prior to enrollment
• Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
• Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of pazopanib therapy; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
• Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
• Patients who are nursing; patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
• Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:
• Active peptic ulcer disease
• Known gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesion are permitted)
• Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease)

Where it is running

• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Saint Vincent Oncology Center — Indianapolis, Indiana, United States
• MedStar Franklin Square Medical Center/Weinberg Cancer Institute — Baltimore, Maryland, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Michigan Cancer Research Consortium CCOP — Ann Arbor, Michigan, United States
• Oakwood Hospital and Medical Center — Dearborn, Michigan, United States
• Saint John Hospital and Medical Center — Detroit, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Genesys Regional Medical Center-West Flint Campus — Flint, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Allegiance Health — Jackson, Michigan, United States
• Sparrow Hospital — Lansing, Michigan, United States
• Saint Mary Mercy Hospital — Livonia, Michigan, United States
• Saint Joseph Mercy Oakland — Pontiac, Michigan, United States
• Saint Joseph Mercy Port Huron — Port Huron, Michigan, United States
• Saint Mary's of Michigan — Saginaw, Michigan, United States
• Saint John Macomb-Oakland Hospital — Warren, Michigan, United States
• Cancer Research for the Ozarks NCORP — Springfield, Missouri, 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.