Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00253565

Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as 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 capecitabine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with capecitabine in treating patients with advanced solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: capecitabine Drug: imatinib mesylate	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	42
Study Start Date:	August 2003

Detailed Description:

OBJECTIVES:

Primary

Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.

Secondary

Determine the non-dose-limiting toxic effects of this regimen in these patients.
Determine, preliminarily, the clinical activity of this regimen in these patients.
Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of imatinib mesylate.

Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused
Previously treated brain metastases that are currently asymptomatic allowed

PATIENT CHARACTERISTICS:

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count > 2,000/mm^3
Platelet count > 100,000 mm^3
Hemoglobin > 9.0 g/dL

Hepatic

Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
SGOT and SGPT < 2.5 times ULN
Bilirubin < 1.5 times ULN

Renal

Creatinine clearance > 50 mL/min

Cardiovascular

No congestive heart failure
No symptomatic coronary artery disease
No uncontrolled cardiac arrhythmias
No myocardial infarction within the past 12 months
No other clinically significant cardiac disease

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No prior unanticipated severe reaction to fluoropyrimidine therapy
No known sensitivity to fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 28 days since prior biologic therapy

Chemotherapy

More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C)

Endocrine therapy

At least 90 days since prior steroids for the treatment of brain metastases
More than 28 days since prior hormonal therapy

Radiotherapy

At least 90 days since prior radiotherapy for the treatment of brain metastases
More than 28 days since other prior radiotherapy
No prior pelvic radiotherapy > 30% of the bone marrow

Surgery

More than 28 days since prior surgery and recovered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253565

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Study Chair:

Herbert I. Hurwitz, MD

Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000448905, DUMC-3992-05-8R3, ROCHE-DUMC-3992-05-8R3, NOVARTIS-DUMC-3992-05-8R3
Study First Received:	November 11, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00253565
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Imatinib
Capecitabine

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009