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

July 25, 2012 updated by: H. Lee Moffitt Cancer Center and Research Institute

Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Overall Response (OR)
Time Frame: From On Treatment to Off Study - average of 6 months
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
From On Treatment to Off Study - average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Progression Free Survival (PFS)
Time Frame: From On Treatment to Off Study - average of 6 months
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).
From On Treatment to Off Study - average of 6 months
Participants' Overall Survival (OS)
Time Frame: From On Treatment to Off Study - average of 6 months
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
From On Treatment to Off Study - average of 6 months
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: 4 years, 7 months
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
4 years, 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Pfizer

Investigators

  • Principal Investigator: Alberto Chiappori, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-14902
  • GA618075 (Other Identifier: Pfizer Pharamaceutic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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