Status:
COMPLETED
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Uterine Sarcoma
Stage III Uterine Sarcoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib. II. Determine the toxic effects of this drug in these patie...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00238121
Start Date
February 1 2005
End Date
July 1 2010
Last Update
November 20 2015
Active Locations (7)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90033-0804
3
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
4
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 60702