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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003592 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more effective in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated with cisplatin.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: methotrexate Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 230 |
Study Start Date: | September 1998 |
Primary Completion Date: | August 2000 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Compare the progression free survival, median survival, and overall survival in cisplatin-ineligible patients with advanced squamous cell carcinoma of the head and neck following weekly outpatient methotrexate (arm I) versus paclitaxel (arm II). II. Compare the response rate of patients in the two treatment arms. III. Compare the Trial Outcome Index scores of patients in the two treatment arms. IV. Compare the weight change, neurologic toxicity, and mucositis scores of patients in the two treatment arms.
OUTLINE: This is a randomized study. Patients are stratified by performance status (0-1 vs 2) and age (less than 60 vs at least 60). Patients are randomized to receive methotrexate IV bolus every week for 4 weeks (arm I) or paclitaxel IV over 1 hour every week for 4 weeks (arm II). All patients receive at least 4 weeks of treatment (1 course). Patients continue treatment for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: There will be 230 patients accrued into this study over 2.4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed advanced, incurable, squamous cell carcinoma of the head and neck Recurrent disease in a previously irradiated field must be biopsy proven or documented unequivocally by physical exam or radiograph(s) Measurable or evaluable disease Patients with ECOG performance status of 0-1 must be ineligible for protocol E-1395 and unable to tolerate cisplatin-based therapy for 1 or more of the following reasons: Hearing loss that precludes cisplatin Unable to handle a fluid load necessitated by cisplatin-based treatment, due to underlying cardiac or pulmonary disease Mild renal insufficiency (creatinine 1.6-2.0 mg/dL) or creatinine clearance of 40-60 mL/min that would make cisplatin treatment difficult, if not dangerous History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy No history of carcinomatous meningitis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 (See Disease Characteristics) Life expectancy: Not specified Hematopoietic:
Absolute neutrophil count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: See Disease Characteristics Creatinine no greater than 2.0 mg/dL No evidence of symptomatic hypercalcemia Cardiovascular: See Disease Characteristics No active angina or uncontrolled arrhythmias Metabolic: No uncontrolled diabetes; no random blood sugar at least 300 mg/dL Neurological: No evidence of ongoing grade 2 or greater peripheral sensory neuropathy Pulmonary: See Disease Characteristics Other: No other concurrent, active, invasive malignancies No significant detectable infection Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except in the adjuvant, neoadjuvant, or radiosensitizing setting No prior chemotherapy for recurrent or persistent disease after definitive local therapy At least 6 months since prior methotrexate or paclitaxel Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery
United States, Georgia | |
Emory University Hospital - Atlanta | |
Atlanta, Georgia, United States, 30322 | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611 | |
Veterans Affairs Medical Center - Chicago (Lakeside) | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
United States, Minnesota | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, New Jersey | |
Veterans Affairs Medical Center - East Orange | |
East Orange, New Jersey, United States, 07018-1095 | |
United States, New York | |
Albert Einstein Comprehensive Cancer Center | |
Bronx, New York, United States, 10461 | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
CCOP - Toledo Community Hospital Oncology Program | |
Toledo, Ohio, United States, 43623-3456 | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Vanderbilt Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 | |
Veterans Affairs Medical Center - Nashville | |
Nashville, Tennessee, United States, 37212 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
Milwaukee, Wisconsin, United States, 53295 | |
South Africa | |
Pretoria Academic Hospital | |
Pretoria, South Africa, 0001 |
Study Chair: | Corey J. Langer, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000066662, E-7397 |
Study First Received: | November 1, 1999 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00003592 History of Changes |
Health Authority: | United States: Federal Government |
stage IV salivary gland cancer recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx |
recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity |
Antimetabolites Immunologic Factors Laryngeal Carcinoma Squamous Cell Carcinoma Hypopharyngeal Cancer Cisplatin Methotrexate Neoplasms, Squamous Cell Salivary Gland Diseases Nasopharyngeal Carcinoma Carcinoma, Squamous Cell of Head and Neck Antimitotic Agents Folic Acid Antagonists |
Immunosuppressive Agents Recurrence Carcinoma Folic Acid Paclitaxel Head and Neck Neoplasms Epidermoid Carcinoma Tubulin Modulators Carcinoma, Squamous Cell Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Neoplasms, Squamous Cell Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type |
Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Head and Neck Neoplasms Tubulin Modulators Antirheumatic Agents Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic |