Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck
Inclusion 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