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Trial record 1 of 1 for:    "Hemangiopericytoma, Malignant" | "Sorafenib"
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S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

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ClinicalTrials.gov Identifier: NCT00217620
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 1, 2012
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Intervention Drug: sorafenib
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sorafenib (BAY 43-9006)
Hide Arm/Group Description Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Period Title: Overall Study
Started 51
Eligible 38
Eligible and Began Protocol Therapy 37
Completed 0
Not Completed 51
Reason Not Completed
Adverse Event             2
Progression             31
Not Protocol Specified             4
Ineligible             13
Never received treatment             1
Arm/Group Title Sorafenib (BAY 43-9006)
Hide Arm/Group Description Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
62.7
(24.0 to 88.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
22
  59.5%
Male
15
  40.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
White 33
Black 3
Pacific Islander 1
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
Leiomyosarcoma 19
Liposarcoma 10
Soft Tissue Sarcoma of Vascular Derivation 8
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
0 15
1 22
[1]
Measure Description: Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
1.Primary Outcome
Title Objective Response (Confirmed, Complete and Partial)
Hide 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 documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.
Time Frame Assessment performed every eight weeks until progression.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in this analysis.
Arm/Group Title Leiomyosarcoma Liposarcoma Vascular Sarcomas
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Number of Participants Analyzed 19 10 8
Measure Type: Number
Unit of Measure: participants
Unconfirmed PR 1 0 1
Stable disease/no response 8 2 5
Progressive disease 9 6 1
Assessment inadequate 1 2 1
2.Secondary Outcome
Title Four-month Progression-free Survival Rate
Hide Description [Not Specified]
Time Frame 0 - 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in this analysis.
Arm/Group Title Leiomyosarcoma Liposarcoma Vascular Sarcomas Total
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Number of Participants Analyzed 19 10 8 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42
(20 to 64)
30
(2 to 58)
63
(29 to 96)
43
(27 to 59)
3.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide 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 events that are possibly, probably or definitely related to study drug are reported.
Time Frame Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Sorafenib (BAY 43-9006)
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1
AST, SGOT 1
Alkaline phosphatase 1
Amylase 1
Bilirubin (hyperbilirubinemia) 1
Constipation 1
Diarrhea 4
Fatigue (asthenia, lethargy, malaise) 2
Hemoglobin 1
Hypertension 2
Lipase 6
Nausea 1
Pain - Abdomen NOS 1
Pancreatitis 1
Platelets 1
Potassium, serum-low (hypokalemia) 2
Rash/desquamation 2
Rash: hand-foot skin reaction 4
Sodium, serum-low (hyponatremia) 2
Vomiting 1
Time Frame Patients assessed for adverse events 2 weeks after starting treatment and then after every cycle (28 days) for the duration of protocol treatment. Assessments continued until resolution of any adverse events up to 5 years after registration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib (BAY 43-9006)
Hide Arm/Group Description Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
All-Cause Mortality
Sorafenib (BAY 43-9006)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib (BAY 43-9006)
Affected / at Risk (%)
Total   10/37 (27.03%) 
Blood and lymphatic system disorders   
Hemoglobin  1  1/37 (2.70%) 
Gastrointestinal disorders   
Constipation  1  1/37 (2.70%) 
Hemorrhage, GI - Colon  1  1/37 (2.70%) 
Nausea  1  1/37 (2.70%) 
Pain - Abdomen NOS  1  3/37 (8.11%) 
Pancreatitis  1  1/37 (2.70%) 
General disorders   
Pain - Chest/thorax NOS  1  1/37 (2.70%) 
Investigations   
AST, SGOT  1  1/37 (2.70%) 
Amylase  1  1/37 (2.70%) 
Lipase  1  2/37 (5.41%) 
Platelets  1  1/37 (2.70%) 
Metabolism and nutrition disorders   
Anorexia  1  1/37 (2.70%) 
Calcium, serum-low (hypocalcemia)  1  1/37 (2.70%) 
Potassium, serum-low (hypokalemia)  1  1/37 (2.70%) 
Sodium, serum-low (hyponatremia)  1  1/37 (2.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  2/37 (5.41%) 
Nervous system disorders   
Mental status  1  1/37 (2.70%) 
Neuropathy: motor  1  1/37 (2.70%) 
Syncope (fainting)  1  1/37 (2.70%) 
Renal and urinary disorders   
Obstruction, GU - Ureter  1  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/37 (2.70%) 
Vascular disorders   
Hypotension  1  1/37 (2.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sorafenib (BAY 43-9006)
Affected / at Risk (%)
Total   37/37 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow-Other (Specify)  1  6/37 (16.22%) 
Hemoglobin  1  8/37 (21.62%) 
Gastrointestinal disorders   
Constipation  1  13/37 (35.14%) 
Diarrhea  1  19/37 (51.35%) 
Flatulence  1  4/37 (10.81%) 
Heartburn/dyspepsia  1  4/37 (10.81%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  6/37 (16.22%) 
Nausea  1  14/37 (37.84%) 
Pain - Abdomen NOS  1  8/37 (21.62%) 
Pain - Oral cavity  1  2/37 (5.41%) 
Vomiting  1  8/37 (21.62%) 
General disorders   
Edema: limb  1  2/37 (5.41%) 
Fatigue (asthenia, lethargy, malaise)  1  23/37 (62.16%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  4/37 (10.81%) 
Immune system disorders   
Allergic reaction/hypersensitivity  1  2/37 (5.41%) 
Infections and infestations   
Infection-Other (Specify)  1  2/37 (5.41%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  8/37 (21.62%) 
AST, SGOT  1  13/37 (35.14%) 
Alkaline phosphatase  1  11/37 (29.73%) 
Amylase  1  7/37 (18.92%) 
Bilirubin (hyperbilirubinemia)  1  3/37 (8.11%) 
Creatinine  1  7/37 (18.92%) 
Leukocytes (total WBC)  1  3/37 (8.11%) 
Lipase  1  9/37 (24.32%) 
Lymphopenia  1  6/37 (16.22%) 
Metabolic/Laboratory-Other (Specify)  1  4/37 (10.81%) 
PTT (Partial thromboplastin time)  1  3/37 (8.11%) 
Platelets  1  2/37 (5.41%) 
Weight loss  1  10/37 (27.03%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  13/37 (35.14%) 
Anorexia  1  15/37 (40.54%) 
Calcium, serum-low (hypocalcemia)  1  3/37 (8.11%) 
Glucose, serum-high (hyperglycemia)  1  6/37 (16.22%) 
Potassium, serum-high (hyperkalemia)  1  2/37 (5.41%) 
Potassium, serum-low (hypokalemia)  1  6/37 (16.22%) 
Sodium, serum-high (hypernatremia)  1  2/37 (5.41%) 
Sodium, serum-low (hyponatremia)  1  10/37 (27.03%) 
Musculoskeletal and connective tissue disorders   
Pain - Back  1  4/37 (10.81%) 
Pain - Bone  1  3/37 (8.11%) 
Pain - Extremity-limb  1  5/37 (13.51%) 
Pain - Joint  1  7/37 (18.92%) 
Pain - Muscle  1  3/37 (8.11%) 
Nervous system disorders   
Neuropathy: sensory  1  5/37 (13.51%) 
Pain - Head/headache  1  5/37 (13.51%) 
Taste alteration (dysgeusia)  1  4/37 (10.81%) 
Psychiatric disorders   
Insomnia  1  4/37 (10.81%) 
Mood alteration - anxiety  1  2/37 (5.41%) 
Renal and urinary disorders   
Renal/Genitourinary-Other (Specify)  1  2/37 (5.41%) 
Urinary frequency/urgency  1  4/37 (10.81%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/37 (5.41%) 
Cough  1  6/37 (16.22%) 
Dyspnea (shortness of breath)  1  3/37 (8.11%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  3/37 (8.11%) 
Voice changes/dysarthria  1  2/37 (5.41%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify)  1  3/37 (8.11%) 
Dry skin  1  7/37 (18.92%) 
Hair loss/Alopecia (scalp or body)  1  14/37 (37.84%) 
Pain - Scalp  1  5/37 (13.51%) 
Pruritus/itching  1  4/37 (10.81%) 
Rash/desquamation  1  14/37 (37.84%) 
Rash: hand-foot skin reaction  1  21/37 (56.76%) 
Vascular disorders   
Flushing  1  4/37 (10.81%) 
Hypertension  1  12/37 (32.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Publications of Results:
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.
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217620     History of Changes
Other Study ID Numbers: NCI-2012-03063
S0505 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000442404 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: October 3, 2012
Results First Posted: November 1, 2012
Last Update Posted: May 15, 2014