Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00483366 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine and capecitabine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine and capecitabine when given together with imatinib mesylate in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: capecitabine Drug: gemcitabine hydrochloride Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Imatinib, Gemcitabine and Capecitabine in Patients With Solid Tumors |
Estimated Enrollment: | 56 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of gemcitabine and capecitabine.
Patients receive oral imatinib mesylate once daily on days 1-5 and 8-12, gemcitabine hydrochloride IV on days 3 and 10, and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of progressive disease or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, meeting 1 of the following criteria:
Measurable or nonmeasurable disease
Nonmeasurable disease is defined as all other lesions, including small lesions (< 20 mm by conventional techniques or < 10 mm by spiral CT scan) and truly nonmeasurable lesions, including the following:
Brain metastases allowed provided both of the following are true:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent anticoagulation therapy with warfarin
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-6805 | |
Contact: Mary Mailliard, RN, BSN, OCN 402-559-5582 mjmailli@unmc.edu |
Study Chair: | Ralph Hauke, MD | University of Nebraska |
Investigator: | Elizabeth C. Reed, MD | University of Nebraska |
Study ID Numbers: | CDR0000547168, UNMC-16306 |
Study First Received: | June 6, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00483366 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Imatinib Capecitabine Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |