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A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)

Phase 2
15 Years
70 Years
Not Enrolling
Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity

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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)


- 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


- 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



- 15 to 70

Performance status:

- WHO 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 150,000/mm^3

- Hemoglobin at least 12 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN


- Creatinine clearance at least 70 mL/min

- Calcium normal


- 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


- 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


Biologic therapy:

- No concurrent immunotherapy


- No prior chemotherapy for UNPC

Endocrine therapy:

- No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis


- No prior radiotherapy for UNPC


- No prior surgery for UNPC except cervical lymphadenectomy


- At least 1 month since prior investigational agent

- No other concurrent anticancer drugs

Type of Study:


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


United States: Federal Government

Study ID:




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