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

June 6, 2001
September 20, 2012
February 2001
April 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00017498 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
Drug: gemcitabine hydrochloride
Not Provided
van Herpen CM, Locati LD, Buter J, Thomas J, Bogaerts J, Lacombe D, de Mulder P, Awada A, Licitra L, Bernier J, Vermorken JB. Phase II study on gemcitabine in recurrent and/or metastatic adenoid cystic carcinoma of the head and neck (EORTC 24982). Eur J Cancer. 2008 Sep 24; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Not Provided
April 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Netherlands
 
NCT00017498
EORTC-24982, EORTC-24982
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Pieter H. M. de Mulder, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP