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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: 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).


Original Primary Outcome: Overall response rate evaluated by Response Evaluation Criteria in Solid Tumors (RECIST)

Current Secondary Outcome:

  • 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).
  • 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.
  • 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.


Original Secondary Outcome:

  • Time to tumor progression defined as the duration of time from start of treatment to time of progression.
  • Overall survival
  • Determine the toxicity of sunitinb malate


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: November 15, 2006
Date Started: November 2006
Date Completion:
Last Updated: July 25, 2012
Last Verified: July 2012