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S0505 Sorafenib in Treating P...

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

Last Updated: 2014-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-09-30

Brief Summary

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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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.

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Detailed Description

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OBJECTIVES:

* Determine the objective response rate (confirmed, complete, and partial) in patients with advanced soft tissue sarcomas treated with sorafenib.
* Determine the 4-month progression-free survival rate in patients treated with this drug.
* Determine the frequency and severity of adverse events in patients treated with this drug.

OTHER OBJECTIVES (if funding permits):

* Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target lesions by positron-emission tomography scan at 4 weeks with response in patients treated with this drug.
* Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the raf/mek/erk pathway with response in patients treated with this drug.
* Correlate, preliminarily, the most common B-raf kinase mutation with response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma).

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

After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this study within 15-38 months.

Conditions

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Sarcoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sorafenib

Group Type EXPERIMENTAL

sorafenib

Intervention Type DRUG

800 mg per day, daily until progression

Interventions

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sorafenib

800 mg per day, daily until progression

Intervention Type DRUG

Other Intervention Names

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BAY 43-9006

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed soft tissue sarcoma of 1 of the following histologies:

* Angiosarcoma, cutaneous or visceral
* Malignant hemangiosarcoma
* Malignant hemangiopericytoma
* Grade 3-4 leiomyosarcoma
* Grade 3-4 liposarcoma
* Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
* Measurable disease by x-ray, scans, or physical examination
* Archived paraffin-embedded tumor sections available
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
* Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
* PT, PTT, and INR normal

Renal

* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min

Cardiovascular

* No history of thromboembolic disease
* No uncontrolled hypertension

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to swallow oral medication
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
* Prior adjuvant chemotherapy allowed
* No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

* Not specified

Radiotherapy

* At least 28 days since prior radiotherapy and recovered

* Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy

Surgery

* At least 28 days since prior major surgery and recovered

Other

* No prior sorafenib
* No prior inhibitor of VEGFR or MAPK pathway
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent therapeutic anticoagulation
* No concurrent administration of any of the following medications:

* Rifampin
* Hypericum perforatum (St. John's wort)
* Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:

* Phenytoin
* Carbamazepine
* Phenobarbital

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret von Mehren, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

George D. Demetri, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

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Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, United States

Site Status

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

California Pacific Medical Center - California Campus

San Francisco, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

M.D. Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Trinity Medical Center - East

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

Bettendorf, Iowa, United States

Site Status