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Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003592
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : January 1, 2019
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Head and Neck Cancer Drug: methotrexate Drug: paclitaxel Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date : September 1998
Actual Primary Completion Date : August 2000
Actual Study Completion Date : March 2, 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003592

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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
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States, 60611
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
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
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Corey J. Langer, MD Fox Chase Cancer Center

Layout table for additonal information Identifier: NCT00003592     History of Changes
Other Study ID Numbers: CDR0000066662
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

Keywords provided by Eastern Cooperative Oncology Group:
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

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents