Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0505 S0505, NCT00217620

Special Category: CTSU trial

Objectives

1. Determine the objective response rate (confirmed, complete, and partial) in patients with advanced soft tissue sarcomas treated with sorafenib.
2. Determine the 4-month progression-free survival rate in patients treated with this drug.
3. Determine the frequency and severity of adverse events in patients treated with this drug.
4. 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.
5. Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the raf/mek/erk pathway with response in patients treated with this drug.
6. Correlate, preliminarily, the most common B-raf kinase mutation with response in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Response rate as measured by RECIST every 8 weeks
Progression-free survival by RECIST every 8 weeks for 4 months
Adverse events by CTC v 3 continuously

Correlation of positron-emission tomography (PET) scan and response as measured by a decrease in standard uptake variable (SUV) at baseline and 4 weeks

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Margaret von Mehren, MD, Protocol chair		Ph: 215-728-3545; 888-369-2427
George Demetri, MD, Protocol co-chair		Ph: 617-632-3985; 866-790-4500 Email: gdemetri@partners.org

Registry Information
Official Title		Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Trial Start Date		2006-03-01
Registered in ClinicalTrials.gov		NCT00217620
Date Submitted to PDQ		2005-07-27
Information Last Verified		2007-02-15
NCI Grant/Contract Number		CA32102

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