SU011248 in Treating Patients With Malignant Gastrointestinal Stromal Tumor
RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known if SU011248 is effective in treating malignant gastrointestinal stromal tumors.
PURPOSE: This randomized phase III trial is studying how well SU011248 works in treating patients with malignant gastrointestinal stromal tumors that have not responded to imatinib mesylate.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of SU011248 in the Treatment of Patients With Imatinib Mesylate (Gleevec™, Glivec®)-Resistant or Intolerant Malignant Gastrointestinal Stromal Tumor|
|Study Start Date:||March 2004|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
- Compare the time to tumor progression in patients with imatinib mesylate-resistant or -intolerant malignant gastrointestinal stromal tumor treated with SU011248 vs placebo.
- Compare other measures of antitumor efficacy of these regimens in these patients.
- Compare pain control, analgesic usage, tumor-related signs and symptoms, health status, and performance status in patients treated with these regimens.
- Determine the safety and tolerability of SU011248 in these patients.
- Correlate plasma concentration of this drug with efficacy and safety parameters in these patients.
- Correlate potential biomarkers with clinical outcomes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior imatinib mesylate response or intolerance (progressive disease within 6 months of the start of therapy vs progressive disease beyond 6 months from the start of therapy vs intolerance) and baseline MPQ score based on the median value of the worst daily pain over a 7-day period before randomization (0 vs ≥ 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral SU011248 once daily on days 1-28.
- Arm II: Patients receive oral placebo once daily on days 1-28. In both arms, courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients in arm II with disease progression who meet all eligibility criteria for further treatment may crossover to arm I to receive open-label treatment with SU011248.
Quality of life is assessed on days 1 and 28 of each course and at the end of study treatment.
Patients are followed at 30 days and then every 2 months for up to 3 years.
PROJECTED ACCRUAL: A total of 357 patients (238 in arm I and 119 in arm II) will be accrued for this study within 18 months.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-7059|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021-6007|
|Principal Investigator:||Robert Maki, MD, PhD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||David R. D'Adamo, MD, PhD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Peter J. Rosen, MD||Jonsson Comprehensive Cancer Center|