Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland adenoid cystic carcinoma, stage IV adenoid cystic carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity
Eligibility Criteria
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
Sites / Locations
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Ospedale Santa Croce
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Vrije Universiteit Medisch Centrum
- University Medical Center Nijmegen