Overview

This trial is active, not recruiting.

Conditions chemotherapeutic agent toxicity, head and neck cancer, mucositis, radiation toxicity, xerostomia
Treatments amifostine trihydrate, carboplatin, paclitaxel, radiation therapy
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date May 2003
End date June 2009
Trial size 90 participants
Trial identifier NCT00095927, CDR0000393493, DFCI-03018

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in 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 chemotherapy with radiation therapy may kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: This randomized phase II trial is studying giving amifostine together with radiation therapy, carboplatin, and paclitaxel to see how well it works compared to radiation therapy, carboplatin, and paclitaxel in treating patients with newly diagnosed stage II, stage III, or stage IV head and neck cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment
Arm
(Active Comparator)
Patients receive carboplatin and paclitaxel once weekly for 6 weeks. Patients also undergo radiotherapy, concurrently with chemotherapy, once daily for 4 weeks and then twice daily for 2 weeks.
carboplatin
Given IV
paclitaxel
Given IV
radiation therapy
Given once daily for 4 weeks and then twice daily for 2 weeks.
(Experimental)
Patients receive chemoradiotherapy as in arm I. Patients also receive amifostine subcutaneously once daily.
amifostine trihydrate
Given subcutaneously
carboplatin
Given IV
paclitaxel
Given IV
radiation therapy
Given once daily for 4 weeks and then twice daily for 2 weeks.

Primary Outcomes

Measure
Rate of local/regional control (LRC) 1 year after beginning treatment
time frame:
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6, and 12 months after completion of study treatment
time frame:
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
time frame:
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
time frame:

Secondary Outcomes

Measure
Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
time frame:
Proportion of patients with PEG dependency at 3, 6, and 12 months after completion of study treatment
time frame:
Time to disease progression
time frame:
Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey at baseline and 8, 12, 24, and 52 weeks after completion of study treatment
time frame:
LRC and overall survival at 2 years after completion of study treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Stage II, III, or IV disease - No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function abnormalities) or bone scan (for patients with local symptoms) - Biopsy preferred unless medically contraindicated - One of the following primary tumor sites: - Oral cavity - Oropharynx - Hypopharynx - Larynx - Nasal cavity - Paranasal cavity - Unknown primary with metastasis to the head and neck region - At least 1 uni- or bi-dimensionally measurable lesion - No prior curative surgery for head and neck cancer - Biopsy allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-1 Life expectancy - More than 12 weeks Hematopoietic - Neurophil count ≥ 2,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL Hepatic - Bilirubin normal - AST and ALT ≤ 2.5 times upper limit of normal (ULN)* - Alkaline phosphatase ≤ 5 times ULN* NOTE: *Patients with AST or ALT > 1.5 times ULN AND alkaline phosphatase > 2.5 times ULN are not eligible Renal - Creatinine clearance ≥ 60 mL/min Cardiovascular - No unstable cardiac disease despite treatment - No myocardial infarction within the past 6 months Pulmonary - No chronic obstructive pulmonary disease requiring hospitalization within the past year Other - No symptomatic peripheral neuropathy ≥ grade 2 - No weight loss > 20% of body weight within the past 3 months (unless purposeful) - No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy Chemotherapy - Prior induction chemotherapy for head and neck cancer allowed before radiotherapy begins Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the head and neck Surgery - See Disease Characteristics

Additional Information

Official title Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Description OBJECTIVES: Primary - Compare the 1-year rate of local and regional disease control in patients with newly diagnosed stage II, III, or IV squamous cell carcinoma of the head and neck treated with concurrent radiotherapy and chemotherapy comprising carboplatin and paclitaxel with vs without amifostine. - Compare the 3- and 6-month incidence of grade 2 or 3 chronic xerostomia in patients treated with these regimens. - Compare the incidence of grade 3 and 4 mucositis after radiotherapy in patients treated with these regimens. - Compare the median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition in patients treated with these regimens. Secondary - Compare the duration of grade 3 and 4 mucositis in patients treated with these regimens. - Compare the 3-, 6-, and 12-month dependence on PEG in patients treated with these regimens. - Compare time to disease progression in patients treated with these regimens. - Compare quality of life of patients treated with these regimens. - Compare 2-year local and regional disease control in patients treated with these regimens. - Compare 2-year survival of patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive carboplatin and paclitaxel once weekly for 6 weeks. Patients also undergo radiotherapy, concurrently with chemotherapy, once daily for 4 weeks and then twice daily for 2 weeks. - Arm II: Patients receive chemoradiotherapy as in arm I. Patients also receive amifostine subcutaneously once daily. Quality of life is assessed at baseline and then at 8, 12, 24, and 52 weeks after completion of study therapy. Patients are followed at 8, 12, 24, and 52 weeks. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).