Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00253565

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2010-07-31

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

capecitabine

Intervention Type: DRUG

imatinib mesylate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Hurwitz

OTHER

Sponsor Role: lead

Responsible Party

Herbert Hurwitz

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Herbert I. Hurwitz, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

References

Dugan E, Truax R, Meadows KL, Nixon AB, Petros WP, Favaro J, Fernando NH, Morse MA, Blobe GC, Hurwitz HI. A phase I dose-escalation study of imatinib mesylate (Gleevec/STI571) plus capecitabine (Xeloda) in advanced solid tumors. Anticancer Res. 2010 Apr;30(4):1251-6.

Reference Type: RESULT

PMID: 20530436 (View on PubMed)

Other Identifiers

DUMC-3992-05-8R3

Identifier Type: -

Identifier Source: secondary_id

ROCHE-DUMC-3992-05-8R3

Identifier Type: -

Identifier Source: secondary_id

NOVARTIS-DUMC-3992-05-8R3

Identifier Type: -

Identifier Source: secondary_id

CDR0000448905

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00009521

Identifier Type: -

Identifier Source: org_study_id