RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIB, stage III, or stage IV cancer of the nasopharynx.

Condition	Treatment or Intervention	Phase
stage II nasopharyngeal cancer stage III nasopharyngeal cancer stage IV nasopharyngeal cancer	Drug: cisplatin  Drug: docetaxel  Drug: filgrastim  Drug: fluorouracil  Drug: leucovorin calcium	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--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

--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

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

A. Dimitrios Colevas,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000067408; DFCI-99132; NCI-G99-1631; RP-DFCI-99132
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004164
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08