Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma
About this trial
This is an interventional treatment trial for Recurrent Uterine Sarcoma
Eligibility Criteria
Inclusion Criteria: No prior sorafenib Histologically or cytologically confirmed uterine carcinoma or carcinosarcoma: Advanced or recurrent disease Not amenable to curative surgery or radiotherapy Measurable disease: At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Tumor tissue block must be available No known brain metastases Performance status: ECOG 0-2 OR Karnofsky 60-100% Hematopoietic: Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis Hepatic: Bilirubin normal AST and ALT =< 2.5 times upper limit of normal Renal: Creatinine =< 1.5 mg/dL OR Creatinine clearance >= 60 mL/min Cardiovascular: No uncontrolled hypertension, defined by 1 of the following: Blood pressure > 150/100 mm Hg Currently taking > 1 antihypertensive agent Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other active malignancy No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No swallowing dysfunction that would preclude study drug ingestion No other uncontrolled illness Prior biological response modifier therapy allowed No prior antiangiogenesis therapy No prior MAPK-signaling agents No prior vascular endothelial growth factor receptor (VEGFR) inhibitors No more than 1 prior chemotherapy regimen More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Prior hormonal therapy allowed Prior radiotherapy allowed provided the only site of measurable disease was not located within the radiation port OR disease has progressed since completion of therapy Recovered from all prior therapy Concurrent warfarin allowed provided all of the following are true: Patient is therapeutic on a stable warfarin dose INR target range =< 3 Patient is monitored with weekly INR testing No active bleeding or pathological condition that carries a high bleeding risk No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) No concurrent rifampin No concurrent Hypericum perforatum (St. John's wort) No other concurrent investigational agents No other concurrent anticancer therapy More than 4 weeks since prior radiotherapy
Sites / Locations
- City of Hope Medical Center
- University of Southern California
- Decatur Memorial Hospital
- Central Illinois Hematology Oncology Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- University Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.