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| Sponsor: | Vanderbilt-Ingram Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Jordan Berlin, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00573404 |
Purpose
RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate given together with sunitinib in treating patients with gastrointestinal stromal tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Drug: sunitinib malate Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors |
| Enrollment: | 6 |
| Study Start Date: | July 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Therapeutic Intervention |
Drug: imatinib mesylate
will start at 200 mg daily and will be escalated up to 400 mg bid.If the 400 mg bid dose is tolerated, no further dose escalation will be performed. In the case of excessive toxicity on the starting dose, the option for de-escalation is provided. Sunitinib will start at 25 mg daily and if tolerated, will be escalated to 37.5 mg daily for subsequent dose levels.
Other Name: None noted
Drug: sunitinib malate
Not specified
Other Name: none noted
Other: pharmacological study
Not specified
Other Name: Not noted
|
OBJECTIVES:
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42 in all subsequent courses. Beginning in course 2, patients also receive oral imatinib mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of unacceptable toxicity.
Blood samples are collected on day 15 and day 43 for pharmacokinetics.
After completion of study treatment, patients are followed every 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients previously treated with imatinib mesylate must have documented progression of disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Principal Investigator: | Jordan D. Berlin, MD | Vanderbilt-Ingram Cancer Center |
| Principal Investigator: | Charles D. Blanke, MD, FACP | OHSU Knight Cancer Institute |
| Principal Investigator: | Emily Chan, MD, PhD | Vanderbilt-Ingram Cancer Center |
More Information
| Responsible Party: | Jordan Berlin, Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00573404 History of Changes |
| Obsolete Identifiers: | NCT00495001 |
| Other Study ID Numbers: | VICC GI 0621, P30CA068485, VU-VICC-GI-0621 |
| Study First Received: | December 13, 2007 |
| Last Updated: | November 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Imatinib Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |