Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally … (NCT00025298) | Clinical Trial Compass
TerminatedPhase 2
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
Stopped: low accrual
Belgium, France5 participantsStarted 2001-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.
Who can participate
Age range15 Years – 70 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)
* Locoregionally advanced disease
* T2b, N1 (greater than 3 cm) or N2
* T3, N1 (greater than 3 cm) or N2
* T4, N1 (greater than 3 cm) or N2
* Any T, N3
* No squamous cell histology
* At least 1 unidimensionally measurable target lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* No evidence of distant metastases
* No signs or symptoms of CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 15 to 70
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 150,000/mm\^3
* Hemoglobin at least 12 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal:
* Creatinine clearance at least 70 mL/min
* Calcium normal
Cardiovascular:
* No hypotension or hypertension requiring therapy
* No prior myocardial infraction
* No pre-existing uncontrolled cardiac disease
* No signs of cardiac failure
* No rhythm disturbances requiring medication
Other:
* No sensory neuropathy grade 2 or greater unless due to cranial nerve
* No uncontrolled infections
* No sensitivity to aminothiol compounds
* No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No psychological, fa…
Trial details
NCT IDNCT00025298
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC