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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004094 |
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth, pharynx, or larynx.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: carboplatin Drug: fluorouracil Drug: hydroxyurea Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes weekly for 3 weeks.
Treatment repeats every 4 weeks for 2 courses.
At 1-2 weeks after completion of induction chemotherapy, patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, radiotherapy twice daily on days 1-5, and paclitaxel IV over 1 hour on day 2. Treatment repeats every 2 weeks for 5 courses.
Patients with residual nodal disease or initially staged nodal disease in the absence of macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy. Patients with residual disease at the primary site undergo complete excision of disease. Patients with disease progression or disease recurrence are considered for conventional surgical management.
Quality of life is assessed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 15 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the head and neck
Measurable disease desirable
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, Illinois | |
Monroe Medical Associates | |
Chicago, Illinois, United States, 60603 | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 |
Study Chair: | Athanassios Argiris, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067310, NU-C98N1, UCCRC-9502, NCI-G99-1587 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004094 History of Changes |
Health Authority: | United States: Federal Government |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx |
stage IV lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx |
Antimetabolites Nasopharyngeal Carcinoma Immunologic Factors Hydroxyurea Laryngeal Carcinoma Antimitotic Agents Carboplatin Squamous Cell Carcinoma Immunosuppressive Agents Mouth Neoplasms |
Carcinoma Oral Cancer Hypopharyngeal Cancer Paclitaxel Head and Neck Neoplasms Fluorouracil Tubulin Modulators Epidermoid Carcinoma Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic |
Antimetabolites Antisickling Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Hydroxyurea Antineoplastic Agents Mitosis Modulators Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Carboplatin Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Head and Neck Neoplasms Fluorouracil Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Nucleic Acid Synthesis Inhibitors |