A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
carboplatin
+ etoposide
+ fluorouracil
Métastase de néoplasie+3
+ Néoplasmes
+ Processus Néoplasiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Compare the overall survival after treatment with paclitaxel, carboplatin, and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary. Compare the response rates, progression free survival, toxicity profile, and quality of life between the two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence or absence of liver metastases. Patients are randomly assigned to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to four courses. Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two courses. Patients are followed every 3 months after treatment for 1 year or until death. Quality of life questionnaires are completed at each follow-up. PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3 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.140 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.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 confirmed adenocarcinoma of any differentiation grade Excludes the following "treatable" conditions: Axillary node involvement Peritonitis carcinomatosis Blastic bone metastases and/or elevated PSA Squamous cell cancer with cervical or inguinal presentation Poorly differentiated carcinoma Neuroendocrine tumors OR Tumors located in the mediastinum, retroperitoneum, or nodes At least one measurable metastatic site No brain or meningeal metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Hematopoietic: Leukocyte count at least 4,000/mm3 Thrombocyte count at least 100,000/mm3 Hepatic: Bilirubin less than 1.4 mg/dL AST and ALT less than 3 times upper limit of normal No cirrhosis of the liver Renal: Creatinine less than 1.7 mg/dL Cardiovascular: At least 3 months since myocardial infarction No congestive heart failure, tachydysrhythmia, or unstable angina pectoris Other: Not pregnant or nursing Negative pregnancy test No active infection No other serious illness or medical condition No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow) Surgery: Not specified
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 2 sites
Academisch Ziekenhuis Maastricht
Maastricht, NetherlandsOuvrir Academisch Ziekenhuis Maastricht dans Google MapsSt. Elisabeth Ziekenhuis
Tilburg, Netherlands