Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Amifostine; Carboplatin; Paclitaxel

Criteria

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, familial, sociological, or geographical condition that would preclude study

• Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy for UNPC

Endocrine therapy:

• No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis

Radiotherapy:

• No prior radiotherapy for UNPC

Surgery:

• No prior surgery for UNPC except cervical lymphadenectomy

Other:

• At least 1 month since prior investigational agent

• No other concurrent anticancer drugs