Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

European Organisation for Research and Treatment of Cancer - EORTC21 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.

OBJECTIVES: * Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck. * Determine the acute toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Head and Neck Cancer

Interventions

gemcitabine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist * Symptomatic and/or progressive disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No bone metastases as only lesion * Prior radiotherapy to only target lesion allowed if it has progressed or reappeared after radiotherapy * No CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) (2.5 times ULN if liver metastases present) * AST or ALT less than 3 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.7 mg/dL Other: * No uncontrolled infection * No concurrent serious systemic disorders that would preclude study * No other prior or concurrent malignancy except: * Adequately treated carcinoma in situ of the cervix * Basal cell or squamous cell skin cancer * Any malignancy that occurred more than 5 years ago with no symptoms or signs of recurrence (except malignant melanoma, hypernephroma, or breast carcinoma) * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent anti-estrogen therapy * Concurrent steroid replacement or steroids as an antiemetic allowed Radiotherapy: * See Disease Characteristics * At least 3 months since prior radiotherapy except for palliative radiotherapy to bone lesions * No concurrent radiotherapy Surgery: * Not specified Other: * At least 1 month since prior investigational agents * No other concurrent experimental medications

Locations (7)

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

U.Z. Gasthuisberg

Leuven, Belgium

Ospedale Santa Croce

Cuneo, Italy

Data from ClinicalTrials.gov

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