Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253565
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: capecitabine Drug: imatinib mesylate Phase 1

Detailed Description:



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


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
Study Start Date : August 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


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


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


  • Creatinine clearance > 50 mL/min


  • 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


  • 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


Biologic therapy

  • More than 28 days since prior biologic therapy


  • 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


  • 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


  • More than 28 days since prior surgery and recovered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253565

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Herbert Hurwitz
National Cancer Institute (NCI)
Study Chair: Herbert I. Hurwitz, MD Duke Cancer Institute

Publications of Results:
Responsible Party: Herbert Hurwitz, Associate Professor, Duke University Identifier: NCT00253565     History of Changes
Other Study ID Numbers: Pro00009521
CDR0000448905 ( Other Identifier: NCI )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Herbert Hurwitz, Duke University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Imatinib Mesylate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors