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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pieter H. M. de Mulder, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitair Medisch Centrum St. Radboud - Nijmegen

Authority:

United States: Federal Government

Study ID:

EORTC-24982

NCT ID:

NCT00017498

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Adenoid Cystic
  • Head and Neck Neoplasms

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