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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Jonsson Comprehensive Cancer Center |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085618 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: sunitinib malate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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) |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Imatinib mesylate-resistant or -intolerant disease (last dose administered ≥ 2 weeks ago)
Failed prior imatinib mesylate therapy, defined by disease progression during treatment OR significant toxicity during treatment that precludes further treatment
Intolerance to prior imatinib mesylate, defined by 1 of the following:
Unidimensionally measurable disease
At least 1 tumor mass ≥ 20 mm by conventional radiographic techniques or MRI OR ≥ 10-16 mm by spiral CT scan
The following are considered non-measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following conditions within the past 12 months:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy to the sole site of measurable disease
Surgery
Other
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00085618 History of Changes |
| Other Study ID Numbers: | CDR0000370830, MSKCC-04028, PFIZER-A6181004, UCLA-0311021-01 |
| Study First Received: | June 10, 2004 |
| Last Updated: | December 13, 2009 |
| Health Authority: | United States: Federal Government |
|
gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |