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Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Primary Purpose

Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sorafenib tosylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Uterine Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 12, 2005
Last Updated
November 17, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238121
Brief Title
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Official Title
A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 treating patients with advanced or recurrent uterine cancer.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Objective Overall Response Rate
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
Up to 5 years
Title
Progression Free Survival
Description
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.
Time Frame
Up to 5 years
Title
Duration of Response
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gini Fleming
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
60702
Country
United States
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

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