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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00400569
First received: November 15, 2006
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Liposarcoma
Leiomyosarcoma
Fibrosarcoma
Malignant Fibrous Histiocytoma
Drug: Sunitinib Malate (SU011248)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants With Overall Response (OR) [ Time Frame: From On Treatment to Off Study - average of 6 months ] [ Designated as safety issue: No ]
    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 Frame: From On Treatment to Off Study - average of 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: From On Treatment to Off Study - average of 6 months ] [ Designated as safety issue: No ]
    The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 4 years, 7 months ] [ Designated as safety issue: Yes ]
    Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.


Enrollment: 48
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib Malate (SU011248) Treatment
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400569

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Pfizer
Investigators
Principal Investigator: Alberto Chiappori, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00400569     History of Changes
Other Study ID Numbers: MCC-14902, GA618075
Study First Received: November 15, 2006
Results First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Sunitinib malate
SUTENT
SU011248
Soft tissue sarcoma
Gastrointestinal stromal tumors (GIST)
MFH
Tyrosine kinase inhibitor
Imatinib mesylate
Phase II

Additional relevant MeSH terms:
Fibrosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Leiomyosarcoma
Liposarcoma
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Muscle Tissue
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014