Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

NCT00400569

Last updated date
Study Location
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Malignant Fibrous Histiocytoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Malignant Fibrous HistiocytomaPhase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
NCT00400569
  1. Tampa, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Official Title  ICMJE Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liposarcoma
  • Leiomyosarcoma
  • Fibrosarcoma
  • Malignant Fibrous Histiocytoma
Intervention  ICMJE Drug: Sunitinib Malate (SU011248)
For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.
Other Names:
  • Sutent
  • SU011248
Study Arms  ICMJE Experimental: Sunitinib Malate (SU011248) Treatment
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Intervention: Drug: Sunitinib Malate (SU011248)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2006)
48
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00400569
Other Study ID Numbers  ICMJE MCC-14902
GA618075 ( Other Identifier: Pfizer Pharamaceutic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alberto Chiappori, M.D.H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP