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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003592

Collaborator

National Cancer Institute (NCI) (NIH)

230

Enrollment

Locations

Actual Duration (Months)

11.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 1998

Actual Primary Completion Date :

Aug 1, 2000

Actual Study Completion Date :

Mar 2, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
2	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
3	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611
4	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois	United States	60611
5	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
8	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
9	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
10	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
11	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
12	University of Rochester Cancer Center	Rochester	New York	United States	14642
13	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
14	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
15	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
16	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
17	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
18	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
19	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
20	Pretoria Academic Hospital	Pretoria		South Africa	0001