NCT00238121

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

June 10, 2014

Completed
Last Updated

November 20, 2015

Status Verified

January 1, 2014

Enrollment Period

5.4 years

First QC Date

October 12, 2005

Results QC Date

December 23, 2013

Last Update Submit

November 17, 2015

Conditions

Recurrent Uterine SarcomaStage III Uterine SarcomaStage IV Uterine SarcomaUterine Carcinosarcoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Overall Survival

    Up to 5 years

  • Progression Free Survival

    Up to 5 years

  • Duration of Response

    Up to 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: sorafenib tosylate

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +40 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 60702, United States

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Gini Fleming
Organization
University of Chicago Comprehensive Cancer Center
gfleming@medicine.bsd.uchicago.edu
773-702-6712

Study Officials

  • Gini Fleming

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

February 1, 2005

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 20, 2015

Results First Posted

June 10, 2014

Record last verified: 2014-01

Locations

CA(3)US(4)