Clinical Trial: Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

Brief Summary:

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.


Detailed Summary:

OBJECTIVES:

Primary

  • To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.

Secondary

  • To determine the efficacy and safety of dasatinib in these patients.
  • To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.
  • To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.
  • To determine the efficacy of second-line treatment with another TK-inhibitor.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.


Sponsor: Swiss Group for Clinical Cancer Research

Current Primary Outcome: Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria [ Time Frame: at 4 weeks compared to baseline ]

Original Primary Outcome: Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria at 4 weeks compared to baseline

Current Secondary Outcome:

  • Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ]
  • Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ]
  • Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ]
  • Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ]
  • Progression-free survival [ Time Frame: calculated from registration until progression or death ]
  • Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ]
  • Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ]
  • Adverse drug reactions according to NCI CTCAE v3.0 [ Time Frame: Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0. ]


Original Secondary Outcome:

  • Best response as assessed by CT scan/MRI according to RECIST criteria
  • Best response as assessed by fusion PET/CT scan
  • Clinical benefit
  • Time to progression
  • Progression-free survival
  • Time to treatment failure
  • Overall survival
  • Adverse drug reactions according to NCI CTCAE v3.0
  • Mutational status of KIT and PDGFR
  • Best response to second-line treatment with another TK-inhibitor
  • Time to progression while on second-line treatment with another TK-inhibitor


Information By: Swiss Group for Clinical Cancer Research

Dates:
Date Received: December 5, 2007
Date Started: December 2007
Date Completion: December 2018
Last Updated: February 17, 2017
Last Verified: February 2017