Combination Chemotherapy in Treating Patients With Stage IIB, Stage III, or Stage IV Cancer of the Nasopharynx
A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: A. Dimitrios Colevas, MD, NCI - Investigational Drug Branch
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Neubildungen nach Standort
- Kopf-Hals-Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Schutzmittel
- Mikronährstoffe
- Vitamine
- Calciumregulierende Hormone und Wirkstoffe
- Gegenmittel
- Vitamin B-Komplex
- Docetaxel
- Cisplatin
- Fluorouracil
- Leucovorin
- Kalzium
- Levoleucovorin
Andere Studien-ID-Nummern
- CDR0000067408
- DFCI-99132
- RP-DFCI-99132
- NCI-G99-1631
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