Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
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ClinicalTrials.gov Identifier: NCT00238121 |
Recruitment Status
:
Completed
First Posted
: October 13, 2005
Results First Posted
: June 10, 2014
Last Update Posted
: November 20, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Uterine Sarcoma Stage III Uterine Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma | Drug: sorafenib tosylate | Phase 2 |
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 patients.
SECONDARY OBJECTIVES:
I. Determine progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to histology (carcinoma vs carcinosarcoma).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: sorafenib tosylate
Given orally
Other Names:
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- Objective Overall Response Rate [ Time Frame: Up to 5 years ]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.
- Overall Survival [ Time Frame: Up to 5 years ]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.
- Progression Free Survival [ Time Frame: Up to 5 years ]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.
- Duration of Response [ Time Frame: Up to 5 years ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
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Hematopoietic:
- Absolute neutrophil count >= 1,500/mm3
- Platelet count >= 100,000/mm3
- No bleeding diathesis
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Hepatic:
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
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Renal:
- Creatinine =< 1.5 mg/dL OR
- Creatinine clearance >= 60 mL/min
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Cardiovascular:
-
No uncontrolled hypertension, defined by 1 of the following:
- Blood pressure > 150/100 mm Hg
- Currently taking > 1 antihypertensive agent
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- 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238121
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010 | |
University of Southern California | |
Los Angeles, California, United States, 90033-0804 | |
United States, Illinois | |
Decatur Memorial Hospital | |
Decatur, Illinois, United States, 62526 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 60702 | |
Canada, Ontario | |
Juravinski Cancer Centre at Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 5P9 | |
University Health Network-Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Gini Fleming | University of Chicago Comprehensive Cancer Center |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238121 History of Changes |
Other Study ID Numbers: |
NCI-2009-00068 13572A CDR0000445181 N01CM62203 ( U.S. NIH Grant/Contract ) |
First Posted: | October 13, 2005 Key Record Dates |
Results First Posted: | June 10, 2014 |
Last Update Posted: | November 20, 2015 |
Last Verified: | January 2014 |
Additional relevant MeSH terms:
Sarcoma Carcinosarcoma Mixed Tumor, Mullerian Uterine Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases |
Genital Diseases, Female Sorafenib Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |