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

Phase 3

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00003592
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 1999-04-22
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-08
• Study Completion: 2004-03-02
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

Emory University Hospital - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur); 🇺🇸 Decatur, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Lakeside); 🇺🇸 Chicago, Illinois, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

CCOP - Metro-Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

Veterans Affairs Medical Center - East Orange; 🇺🇸 East Orange, New Jersey, United States

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