A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx
filgrastim
+ cisplatin
+ docetaxel
Stomatognathic Diseases+7
+ Nasopharyngeal Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the complete and overall response rate to docetaxel, cisplatin, fluorouracil, and leucovorin calcium in patients with potentially curable nasopharyngeal cancer. II. Assess the tolerability of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour followed 1 hour later by cisplatin IV over 4 hours and fluorouracil IV and leucovorin calcium IV over 96 hours. Filgrastim (G-CSF) is administered subcutaneously beginning on day 5 and continuing until blood counts recover or day 10. Treatment repeats every 3 weeks for up to 3 courses. Within 2 weeks after the completion of chemotherapy, patients undergo definitive radiotherapy for about 7 weeks. After radiotherapy, patients who did not achieve complete remission after chemotherapy may undergo surgery. Patients are followed monthly for 1 year, then every 3 months thereafter. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven, previously untreated stage IIB, III, or IV carcinoma of the nasopharynx Metastatic disease must be limited to site amenable to curative irradiation or surgical resection Locally recurrent disease after surgery allowed Evaluable disease No prior head and neck cancer, unless treated solely by surgery PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3000/mm3 OR Absolute neutrophil count at least 1000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN (no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN if SGOT/SGPT no greater than ULN) Alkaline phosphatase has no ULN if known bony invasion present and all other hepatic enzymes normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease Other: No other concurrent or prior malignancy within the past 3 years except limited basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No grade 2 or worse peripheral neuropathy No other serious illness or medical condition Adequate and nutritionally balanced enteral intake No requirement for intravenous alimentation as primary source of calories Able to tolerate 3-4 liters of IV saline per day Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for nasopharyngeal cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for nasopharyngeal cancer Surgery: See Disease Characteristics Recovered from prior surgery Other: Recovered from prior diagnostic or therapeutic procedures
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Massachusetts General Hospital Cancer Center
Boston, United StatesOpen Massachusetts General Hospital Cancer Center in Google MapsDana-Farber Cancer Institute
Boston, United States