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A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Herbert I. Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

Pro00009521

NCT ID:

NCT00253565

Start Date:

August 2003

Completion Date:

July 2010

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710