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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095927 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Head and Neck Cancer |
Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | May 2003 |
Arms | Assigned Interventions |
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Arm I: 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.
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Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: radiation therapy
Given once daily for 4 weeks and then twice daily for 2 weeks.
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Arm II: Experimental
Patients receive chemoradiotherapy as in arm I. Patients also receive amifostine subcutaneously once daily.
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Drug: amifostine trihydrate
Given subcutaneously
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: radiation therapy
Given once daily for 4 weeks and then twice daily for 2 weeks.
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
Stage II, III, or IV disease
One of the following primary tumor sites:
No prior curative surgery for head and neck cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
Bethke Cancer Center at Emerson Hospital | Recruiting |
Concord, Massachusetts, United States, 01742 | |
Contact: Clinical Trials Office - Bethke Cancer Center at Emerson Hospi 978-287-3460 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Robert I. Haddad, MD 617-632-3090 | |
NSMC Cancer Center - Peabody | Recruiting |
Peabody, Massachusetts, United States, 01960 | |
Contact: James F. McIntyre, MD 987-977-9400 jfmcintyre@partners.org | |
Lowell General Hospital | Recruiting |
Lowell, Massachusetts, United States, 01854 | |
Contact: Blair Ardman, MD 978-937-6704 | |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Recruiting |
Fall River, Massachusetts, United States, 02721 | |
Contact: Clinical Trials Office - Hudner Oncology Center at Saint Anne' 508-674-5600 ext. 2019 |
Study Chair: | Robert I. Haddad, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000393493, DFCI-03018 |
Study First Received: | November 9, 2004 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00095927 |
Health Authority: | Unspecified |
radiation toxicity chemotherapeutic agent toxicity mucositis xerostomia stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx |
stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity untreated metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma |
Amifostine Mucositis Squamous cell carcinoma Carboplatin Xerostomia Carcinoma Epidermoid carcinoma |
Paclitaxel Head and Neck Neoplasms Metastatic squamous neck cancer with occult primary Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Carcinoma, Squamous Cell |
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Protective Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |