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Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066662

NCT ID:

NCT00003592

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212