A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Collecte de données
Adénocarcinome+12
+ Maladies des voies biliaires
+ Néoplasmes des voies biliaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2002
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine. Secondary * Determine time to disease progression and overall survival of patients treated with this regimen. * Determine quality of life of patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 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.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.Tout sexe
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
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder * Advanced and/or inoperable disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 2 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 3 mg/dL Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy and recovered * No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer * No other prior chemotherapy (except adjuvant therapy) Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies
Centres d'étude
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