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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00017498

EORTC-24982

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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