Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
Capecitabine
+ Imatinib mesylate
Maladies du sein+2
+ Néoplasmes du sein
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.27 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
* Histologically or cytologically confirmed adenocarcinoma of the breast * Stage IV 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 human epidermal growth factor receptor 2 (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 central nervous system (CNS) disease * Hormone Receptor status known * Female age 18 and over * Performance status Zubrod 0-2 * Absolute neutrophil count \> 1,500/mm\^3 * Leukocyte count \> 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin normal * aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 times upper limit of normal * Creatinine normal OR Creatinine clearance \> 60 mL/min * 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 * No prior biologic therapy (e.g., vaccines) * No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia * No prior capecitabine or fluorouracil for metastatic breast cancer * Prior hormonal therapy allowed * More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be the only site of disease * More than 4 weeks since prior major surgery * 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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires