Overview

Combination Chemotherapy in Treating Patients With Stage IIB, Stage III, or Stage IV Cancer of the Nasopharynx

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Calcium
Cisplatin
Docetaxel
Fluorouracil
Leucovorin
Levoleucovorin
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