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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Gemcitabine

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