Uterine Carcinosarcoma Clinical Trial
Official title:
A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | 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 |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | City of Hope Medical Center | Duarte | California |
United States | University of Southern California | Los Angeles | California |
United States | Central Illinois Hematology Oncology Center | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Overall Response Rate | Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR. | Up to 5 years | No |
Secondary | Overall Survival | Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive. | Up to 5 years | No |
Secondary | Progression Free Survival | Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions. | Up to 5 years | No |
Secondary | Duration of Response | Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions. | Up to 5 years | No |
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