Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma

Summary

This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue sarcoma.

Conditions

• Pleomorphic Rhabdomyosarcoma
• Stage IIB Adult Soft Tissue Sarcoma AJCC v7
• Stage III Adult Soft Tissue Sarcoma AJCC v7
• Stage IV Adult Soft Tissue Sarcoma AJCC v7

Interventions

DRUG

Epirubicin Hydrochloride

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Sorafenib Tosylate

Given PO

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

Sponsors & Collaborators

• Bayer

  collaborator INDUSTRY

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Christopher Ryan · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-03

Primary Completion

2018-05-07

Completion

2020-12-31

FDA Drug

Yes

Countries

• United States

Study Locations