Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00087152
First received: July 8, 2004
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Confirmed response rate (complete and partial) [ Designated as safety issue: No ]
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Correlation of c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression [ Designated as safety issue: No ]

Study Start Date: June 2004
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
  • Determine the 6-month progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

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

NOTE: *If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Stage IV disease
  • Measurable disease
  • Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease
  • Patients with hormone-sensitive tumors must have received prior hormonal therapy
  • Patients with HER2/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting (unless contraindicated)
  • No clinical evidence of or known brain or CNS disease
  • Hormone receptor status:

    • Receptor status known

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Leukocyte count > 3,000/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT < 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance > 60 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to imatinib mesylate, capecitabine, or fluorouracil
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior biologic therapy (e.g., vaccines)
  • No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia

Chemotherapy

  • See Disease Characteristics
  • No prior capecitabine or fluorouracil for metastatic breast cancer

Endocrine therapy

  • See Disease Characteristics
  • Prior hormonal therapy allowed

Radiotherapy

  • More than 4 weeks since prior radiotherapy

    • Previously irradiated area(s) must not be the only site of disease

Surgery

  • More than 4 weeks since prior major surgery

Other

  • More than 4 weeks since prior therapy for breast cancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for metastatic breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087152

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Helen K. Chew, MD University of California, Davis
Study Chair: Kathy S. Albain, MD Loyola University
  More Information

Additional Information:
Publications:
Chew HK, Barlow W, Albain K, et al.: SWOG 0338: a phase II trial of imatinib mesylate in combination with capecitabine in metastatic breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-10529, 2006.

Responsible Party: Laurence Baker, D.O., SWOG
ClinicalTrials.gov Identifier: NCT00087152     History of Changes
Other Study ID Numbers: CDR0000372950, U10CA032102, S0338
Study First Received: July 8, 2004
Last Updated: June 16, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Imatinib
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014