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| Sponsor: | Theradex |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003327 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 1997 |
OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.
OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory head and neck cancer Measurable or evaluable disease At least one prior chemotherapy regimen for recurrent or metastatic disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium within normal limits Cardiovascular: No New York Heart Association class III-IV heart disease No myocardial infarction within 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusions or arrhythmias Neurologic: No peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraceptive method Negative pregnancy test No active infection or serious underlying medical condition No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No prior invasive malignancies within the past 2 years, except: Curatively treated basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 5 weeks since prior nitrosoureas, melphalan, or mitomycin At least 3 weeks since other prior chemotherapy Prior taxane therapy allowed only if administered on a 3 week or greater schedule No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 3 weeks since major surgery Other: At least 1 week since prior parenteral antibiotics
Contacts and Locations| United States, California | |
| California Cancer Center | |
| Fresno, California, United States, 93720 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| United States, Florida | |
| Memorial Regional Cancer Center at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Savannah Hematology Oncology Associates | |
| Savannah, Georgia, United States, 31405 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Missouri | |
| Kansas City Internal Medicine | |
| Kansas City, Missouri, United States, 64132 | |
| United States, New York | |
| Lourdes Regional Cancer Center | |
| Binghamton, New York, United States, 13905 | |
| Saint Vincent Catholic Medical Center of New York | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Presbyterian Healthcare | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Medical Oncology Hematology Associates, Inc. | |
| Dayton, Ohio, United States, 45409 | |
| United States, Pennsylvania | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| United States, Texas | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Cancer Care Institute of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Danville Hematology and Oncology, Inc. | |
| Danville, Virginia, United States, 24541 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Arlene A. Forastiere, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00003327 History of Changes |
| Other Study ID Numbers: | CDR0000066279, THERADEX-B97-5250, BMS-TAX/MEN.05, NCI-V98-1415 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage IV nasopharyngeal cancer recurrent nasopharyngeal cancer stage IV lip and oral cavity cancer recurrent lip and oral cavity cancer stage IV hypopharyngeal cancer recurrent hypopharyngeal cancer |
stage IV laryngeal cancer recurrent laryngeal cancer stage IV paranasal sinus and nasal cavity cancer recurrent paranasal sinus and nasal cavity cancer stage IV oropharyngeal cancer recurrent oropharyngeal cancer |
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Paclitaxel Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
