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Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)

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ClinicalTrials.gov Identifier: NCT00330421
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : March 17, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Metastatic Osteosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Osteosarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions Drug: sorafenib tosylate
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: computed tomography
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Enrollment 15
Recruitment Details This phase II study enrolled pts with metastatic or inoperable sarcomas. Additional eligibility criteria: at least one site of measurable disease, at least one superficial palpable tumor (>1cm) amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.
Pre-assignment Details Additional eligibility criteria included: at least one site of measurable disease by radiologic imaging, at least one superficial palpable tumor (>1cm) with no overlying viscera amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.
Arm/Group Title Group II (Metastatic or Inoperable Sarcomas) Group I (Sarcomas of Extremity)
Hide Arm/Group Description

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.

laboratory biomarker analysis : Correlative studies

sorafenib tosylate : Given PO

pharmacological study : Correlative studies

computed tomography : Correlative studies

dynamic contrast-enhanced magnetic resonance imaging : Correlative studies

Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
Period Title: Overall Study
Started 15 0
Completed 15 0
Not Completed 0 0
Arm/Group Title Group II (Metastatic or Inoperable Sarcomas)
Hide Arm/Group Description

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.

laboratory biomarker analysis : Correlative studies

sorafenib tosylate : Given PO

pharmacological study : Correlative studies

computed tomography : Correlative studies

dynamic contrast-enhanced magnetic resonance imaging : Correlative studies

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
59  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)
Hide Description Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Time Frame Baseline to up to 1 month post-treatment
Outcome Measure Data Not Reported
2.Primary Outcome
Title Change in Interstitial Fluid Pressure (IFP)
Hide Description Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Time Frame Baseline to up to 1 month post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.
Arm/Group Title Group II (Metastatic or Inoperable Sarcomas)
Hide Arm/Group Description:

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.

laboratory biomarker analysis : Correlative studies

sorafenib tosylate : Given PO

pharmacological study : Correlative studies

computed tomography : Correlative studies

dynamic contrast-enhanced magnetic resonance imaging : Correlative studies

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: mm Hg
4.25
(3.0 to 5.5)
3.Primary Outcome
Title Change in White Blood Cell Count (WBC)
Hide Description Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Time Frame Baseline to up to 1 month post-treatment
Outcome Measure Data Not Reported
4.Primary Outcome
Title Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA)
Hide Description Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Time Frame Baseline to up to 1 month post-treatment
Outcome Measure Data Not Reported
5.Primary Outcome
Title Clinical Benefit as Measured by 50% Reduction in IFP
Hide Description [Not Specified]
Time Frame Baseline to surgery
Outcome Measure Data Not Reported
6.Primary Outcome
Title Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria
Hide Description [Not Specified]
Time Frame Up to 1 month
Outcome Measure Data Not Reported
7.Primary Outcome
Title Incidence of Adverse Events
Hide Description [Not Specified]
Time Frame Up to 1 month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group II (Metastatic or Inoperable Sarcomas)
Hide Arm/Group Description

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.

laboratory biomarker analysis : Correlative studies

sorafenib tosylate : Given PO

pharmacological study : Correlative studies

computed tomography : Correlative studies

dynamic contrast-enhanced magnetic resonance imaging : Correlative studies

All-Cause Mortality
Group II (Metastatic or Inoperable Sarcomas)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group II (Metastatic or Inoperable Sarcomas)
Affected / at Risk (%) # Events
Total   11/15 (73.33%)    
Blood and lymphatic system disorders   
Hemoglobin * [1]  8/15 (53.33%)  16
Hematologic - other * [2]  6/15 (40.00%)  11
Gastrointestinal disorders   
Diarrhea * [3]  6/15 (40.00%)  11
Abdominal pain * [4]  5/15 (33.33%)  11
General disorders   
Fatigue * [5]  11/15 (73.33%)  22
Anorexia *  5/15 (33.33%)  10
Hepatobiliary disorders   
Alkaline phosphatase * [6]  7/15 (46.67%)  16
AST * [7]  7/15 (46.67%)  16
*
Indicates events were collected by non-systematic assessment
[1]
Low hemoglobin
[2]
Other hematologic issue, including thrombocytopenia and clotting dysfunction
[3]
Diarrhea without prior colostomy
[4]
Abdominal pain
[5]
Fatigue
[6]
Elevated alk phos
[7]
Elevated AST
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group II (Metastatic or Inoperable Sarcomas)
Affected / at Risk (%) # Events
Total   7/15 (46.67%)    
General disorders   
Hand-foot reaction * [1]  7/15 (46.67%)  21
*
Indicates events were collected by non-systematic assessment
[1]
Hand-foot reaction
No Grade 4 toxicities were noted (15 patients). IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey A. Morgan, M.D.
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5204
EMail: jamorgan@partners.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00330421     History of Changes
Other Study ID Numbers: NCI-2012-03122
05-033
U01CA062490 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2006
First Posted: May 26, 2006
Results First Submitted: November 5, 2013
Results First Posted: March 17, 2014
Last Update Posted: April 30, 2014