Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
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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 |
- 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) |
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 |
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 More Information
Additional Information:
Publications:
| 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 May 23, 2013