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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 10, 1999
Last updated: February 6, 2009
Last verified: September 2000

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 Intervention Phase
Head and Neck Cancer
Biological: filgrastim
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1999
Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00004164

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: A. Dimitrios Colevas, MD NCI - Investigational Drug Branch
  More Information Identifier: NCT00004164     History of Changes
Other Study ID Numbers: CDR0000067408
Study First Received: December 10, 1999
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on March 28, 2017