NCT00245102

Brief Summary

This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 20, 2014

Completed
Last Updated

May 23, 2014

Status Verified

December 1, 2012

Enrollment Period

5.5 years

First QC Date

October 25, 2005

Results QC Date

November 19, 2013

Last Update Submit

May 7, 2014

Conditions

Adult AngiosarcomaAdult Epithelioid SarcomaAdult LeiomyosarcomaAdult Malignant Fibrous HistiocytomaAdult NeurofibrosarcomaAdult Synovial SarcomaOvarian SarcomaRecurrent Adult Soft Tissue SarcomaRecurrent Uterine SarcomaStage III Adult Soft Tissue SarcomaStage III Uterine SarcomaStage IV Adult Soft Tissue SarcomaStage IV Uterine SarcomaUterine CarcinosarcomaUterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST

    A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.

    Up to 4 weeks

Study Arms (1)

Arm I

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
Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed sarcoma, including any of the following neoplastic subtypes:
  • Giant hemangioma
  • Angiosarcoma (including epithelioid hemangioendothelioma)
  • Malignant peripheral nerve sheath tumor
  • Leiomyosarcoma (closed to accrual as of 11/29/06)
  • High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous histiocytoma \[including myxofibrosarcoma\]) (closed to accrual as of 11/29/06)
  • Synovial sarcoma (closed to accrual as of 11/29/06)
  • Carcinosarcoma (closed to accrual as of 11/29/06)
  • Metastatic, locally advanced, or locally recurrent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Lesions in a previously irradiated area may be considered measurable provided there is evidence of subsequent disease progression that cannot be attributed to necrosis or bleeding
  • No gastrointestinal stromal tumor
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

HemangiosarcomaSarcomaLeiomyosarcomaHistiocytoma, Malignant FibrousNeurofibrosarcomaSarcoma, Synovial

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueNeoplasms, Muscle TissueHistiocytomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueFibrosarcomaNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. William Tap
Organization
Memorial Sloan-Kettering Cancer Center
tapw@mskcc.org
646-888-4163

Study Officials

  • Robert Maki

    Memorial Sloan Kettering 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 25, 2005

First Posted

October 27, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 23, 2014

Results First Posted

January 20, 2014

Record last verified: 2012-12

Locations

US(1)