Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Primary Purpose
Liposarcoma, Leiomyosarcoma, Fibrosarcoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sunitinib Malate (SU011248)
Sponsored by
About this trial
This is an interventional treatment trial for Liposarcoma focused on measuring Sunitinib malate, SUTENT, SU011248, Soft tissue sarcoma, Gastrointestinal stromal tumors (GIST), MFH, Tyrosine kinase inhibitor, Imatinib mesylate, Phase II
Eligibility Criteria
Inclusion Criteria:
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin less than or equal to 1.5 x ULN
- Absolute neutrophil count (ANC) greater than or equal to1500/microL
- Platelets greater than or equal to 100,000/microL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum calcium less than or equal to 12.0 mg/dL
- Serum creatinine less than or equal to 1.5 x ULN
- Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
- Measurable disease radiographically
- Disease that is deemed surgically unresectable and/or metastatic
- Age greater than or equal to 18 years
- Life expectancy greater than 16 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.
Exclusion Criteria:
- Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
- NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
Any of the following within the 6 months prior to study drug administration:
- myocardial infarction,
- severe/unstable angina,
- coronary/peripheral artery bypass graft,
- symptomatic congestive heart failure,
- cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
- Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec.
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)
- Prior tyrosine kinase inhibitor therapy
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- Concurrent treatment on another clinical trial, except supportive care or non-treatment trials
- Concomitant use of agents known to induce or inhibit CYP3A4
- Concomitant use of agents metabolized by the cytochrome P450 system
- Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed)
- Pregnancy or breastfeeding patients
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sunitinib Malate (SU011248) Treatment
Arm Description
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Outcomes
Primary Outcome Measures
Number of Participants With Overall Response (OR)
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Secondary Outcome Measures
Participants' Progression Free Survival (PFS)
Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Participants' Overall Survival (OS)
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Number of Participants With Serious Adverse Events (SAEs)
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Full Information
NCT ID
NCT00400569
First Posted
November 15, 2006
Last Updated
July 25, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00400569
Brief Title
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Official Title
Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.
All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
Detailed Description
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.
All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Malignant Fibrous Histiocytoma
Keywords
Sunitinib malate, SUTENT, SU011248, Soft tissue sarcoma, Gastrointestinal stromal tumors (GIST), MFH, Tyrosine kinase inhibitor, Imatinib mesylate, Phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunitinib Malate (SU011248) Treatment
Arm Type
Experimental
Arm Description
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Sunitinib Malate (SU011248)
Other Intervention Name(s)
Sutent, SU011248
Intervention Description
For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response (OR)
Description
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame
From On Treatment to Off Study - average of 6 months
Secondary Outcome Measure Information:
Title
Participants' Progression Free Survival (PFS)
Description
Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame
From On Treatment to Off Study - average of 6 months
Title
Participants' Overall Survival (OS)
Description
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Time Frame
From On Treatment to Off Study - average of 6 months
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Time Frame
4 years, 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
Adequate organ function as defined by the following criteria:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
Total serum bilirubin less than or equal to 1.5 x ULN
Absolute neutrophil count (ANC) greater than or equal to1500/microL
Platelets greater than or equal to 100,000/microL
Hemoglobin greater than or equal to 9.0 g/dL
Serum calcium less than or equal to 12.0 mg/dL
Serum creatinine less than or equal to 1.5 x ULN
Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
Measurable disease radiographically
Disease that is deemed surgically unresectable and/or metastatic
Age greater than or equal to 18 years
Life expectancy greater than 16 weeks
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.
Exclusion Criteria:
Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
Any of the following within the 6 months prior to study drug administration:
myocardial infarction,
severe/unstable angina,
coronary/peripheral artery bypass graft,
symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec.
Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)
Prior tyrosine kinase inhibitor therapy
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
Concurrent treatment on another clinical trial, except supportive care or non-treatment trials
Concomitant use of agents known to induce or inhibit CYP3A4
Concomitant use of agents metabolized by the cytochrome P450 system
Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed)
Pregnancy or breastfeeding patients
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Chiappori, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.moffitt.org/
Description
Moffitt Cancer Center Clinical Trials Website
Learn more about this trial
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
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