Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Completed · Phase 2

Conditions studied: Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma

In brief

Sorafenib 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. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.

Key facts

Study ID

NCT00238121

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2005-02-01

Expected to finish

2010-07-01

Last updated by the study team

2015-11-20

Who can join

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

You may qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• University of Southern California — Los Angeles, California, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
• Cancer Centre of Southeastern Ontario at Kingston General Hospital — Kingston, Ontario, Canada
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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