Tucson, Arizona 85724

  • Sarcoma

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000442404


NCT ID:

NCT00217620


Secondary ID:

S0505


Study Acronym:


Brief Title:

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas


Official Title:

Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

51


Enrollment Type:

Actual


Overall Contact Information

Official Name:Margaret von Mehren, MD
Study Chair
Fox Chase Cancer Center

Study Dates

Start Date:March 2006
Completion Date:September 2012
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 2, 2012
First Received Date:September 20, 2005
First Results Date:October 3, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Objective Response (Confirmed, Complete and Partial)
Time Frame:Assessment performed every eight weeks until progression.
Safety Issues:False
Description:Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR
Outcome Type:Secondary Outcome
Measure:Four-month Progression-free Survival Rate
Time Frame:0 - 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Time Frame:Patients were assessed for adverse events two weeks after starting protocol treatment and then after
Safety Issues:True
Description:Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal. Only adverse even

Study Interventions

Intervention Type:Drug
Name:sorafenib
Description:800 mg per day, daily until progression
Arm Name:sorafenib
Other Name:BAY 43-9006

Study Arms

Study Arm Type:Experimental
Arm Name:sorafenib
Description:sorafenib

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Ryan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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