Sorafenib, Epirubicin, Ifosfamide, and Radiation Therapy Followed By Surgery in Treating Patients With High-Risk Stage II or Stage III Soft Tissue Sarcoma

Summary

RATIONALE: 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. Drugs used in chemotherapy, such as epirubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with epirubicin, ifosfamide, and radiation therapy followed by surgery in treating patients with high-risk stage II or stage III soft tissue sarcoma.

Conditions

• Sarcoma

Interventions

DRUG

epirubicin hydrochloride

I.V., days 1-3 of each cycle. Epirubicin to be omitted during cycle 2 (concomitant chemoradiation)

DRUG

ifosfamide

Over 90 minutes I.V., days 1-3 of each cycle. Administered with hydration and Mesna.

DRUG

sorafenib tosylate

P.O. daily beginning 2 weeks before first chemotherapy cycle, held 1 week before and after surgery.

OTHER

immunoenzyme technique

OTHER

immunohistochemistry staining method

OTHER

laboratory biomarker analysis

PROCEDURE

adjuvant therapy

Preoperative administration has been the preference at our institution.

PROCEDURE

neoadjuvant therapy

PROCEDURE

therapeutic conventional surgery

Surgery should be planned for 2-4 weeks after the initiation of chemotherapy for cycle 3.

RADIATION

hypofractionated radiation therapy

28 Gy (350 centigray (cGy) x 8 fractions in 10 days) beginning at the start of cycle 2. \*Boost: postoperative boost of 12 Gy (200 cGy x 6 fractions) for patients with positive surgical margins only.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Christopher W. Ryan, MD · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2012-09-30

Completion

2013-04-30

Countries

• United States

Study Locations