A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
15 Years
70 Years
Both
Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity
Trial Information
A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
OBJECTIVES:
- Compare the overall incidence of grade 3 or 4 mucositis in patients with locally
advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin
followed by cisplatin and radiotherapy with or without amifostine.
- Compare the feasibility and activity of these regimens in these patients.
- Determine the toxicity of paclitaxel and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO
performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs
stable disease vs not evaluable), and participating center.
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses
in the absence of disease progression or unacceptable toxicity.
Patients with a complete or partial response after 2 courses of induction chemotherapy
receive 2 additional courses before randomization. Patients with stable disease after 2
courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly
to randomization. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1, 22, and 43. Patients also undergo
radiotherapy daily 5 days a week for 6.5 weeks.
- Arm II:Patients receive amifostine subcutaneously daily. Patients receive chemotherapy
and radiotherapy as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Lisa Licitra, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Authority:
United States: Federal Government
Study ID:
EORTC-24981
NCT ID:
NCT00025298
Start Date:
July 2001
Completion Date:
Related Keywords:
- Drug/Agent Toxicity by Tissue/Organ
- Head and Neck Cancer
- Oral Complications
- Radiation Toxicity
- stage II nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- oral complications
- drug/agent toxicity by tissue/organ
- radiation toxicity
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
- Radiation Injuries
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