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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00017498
First received: June 6, 2001
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 21
Study Start Date: February 2001
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017498

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Italy
Ospedale Santa Croce
Cuneo, Italy, 12100
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Pieter H. M. de Mulder, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00017498     History of Changes
Other Study ID Numbers: EORTC-24982, EORTC-24982
Study First Received: June 6, 2001
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Adenoid Cystic
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014