A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer
fluorouracil
+ gemcitabine hydrochloride
+ leucovorin calcium
Maladies du système digestif+5
+ Néoplasmes du système digestif
+ Maladies du système endocrinien
Étude thérapeutique
Résumé
Date de début de l'étude : 25 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas. * Determine the toxic effects of this regimen in these patients. * Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen. * Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes (whose protein products are targets of the antineoplastic drugs used in this study) on response to and toxicity of this regimen in these patients. * Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen. OUTLINE: * Neoadjuvant chemotherapy: Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9, and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. * Neoadjuvant chemoradiotherapy: Beginning on day 42, patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42, 49, 56, 63, 70, and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy. * Surgery: Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy. * Adjuvant chemotherapy: After post-operative recovery, patients receive 2 additional courses of gemcitabine, fluorouracil, and leucovorin calcium. If surgical resection is not possible, patients with stable or responsive disease resume gemcitabine, fluorouracil, and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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.29 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.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 19 à 120 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
Inclusion Criteria: * Diagnosis of adenocarcinoma of the pancreas o Locally advanced disease * Potentially resectable disease * 19 years of age and over * Karnofsky 60-100% * Absolute granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 2.0 mg/dL (in the absence of biliary obstruction) * If biliary obstruction is present, patients must undergo biliary decompression * Bilirubin ≤ 3.0 mg/dL after biliary drainage has been established * Creatinine ≤ 1.6 mg/dL Exclusion Criteria: * No early stage resectable disease * No concurrent non-steroidal anti-inflammatory medication * No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging * No symptomatic congestive heart failure * No unstable angina pectoris * No serious uncontrolled cardiac arrhythmia * Not pregnant or nursing * No uncontrolled illness * No active or ongoing infection requiring IV antibiotics * No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine) * No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs * No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma * No prior chemotherapy for pancreatic cancer * No prior abdominal radiotherapy
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site