Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck
filgrastim
+ cisplatin
+ paclitaxel
Carcinome+5
+ Carcinome à cellules squameuses
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2000
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy. Determine the rates of acute and late toxic effects of this regimen in these patients. Determine the pattern of disease progression in patients treated with this regimen. OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection. Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.
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.105 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 proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy Disease must be confined to the head and neck (above the clavicles) No primary SCC of the nasopharynx or salivary gland Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded Measurable disease Ineligible for complete surgical resection No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0 or 1 Life expectancy: No other concurrent illness that would limit survival Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal* Alkaline phosphatase no greater than 2 times normal* * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan Renal: Creatinine no greater than 1.5 mg/dL Other: No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer) No other concurrent illness that would impair tolerance to therapy No grade 2 or worse pre-existing peripheral sensory neuropathy No hypersensitivity to E. coli derived products Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed as a component of the primary treatment No prior chemotherapy for recurrent disease At least 6 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy Surgery: See Disease Characteristics
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
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 235 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOuvrir University of Alabama at Birmingham Comprehensive Cancer Center dans Google MapsComprehensive Cancer Institute of Huntsville
Huntsville, United StatesHuntsville Hospital System
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States