A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx
N/A
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
A. Dimitrios Colevas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Investigational Drug Branch
Authority:
United States: Federal Government
Study ID:
CDR0000067408
NCT ID:
NCT00004164
Start Date:
August 1999
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage II nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
