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Head and Neck CancerPhase 2NCT00017498

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

A Phase 2 study testing gemcitabine hydrochloride in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
gemcitabine hydrochloride
How many people
21 participants
Where
7 sitesin 3 countries
Study dates
Feb 2001to Apr 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Italy2 sites

  • Ospedale Santa Croce

    Cuneo, 12100

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milan, 20133

Other trials in Italy

Netherlands2 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Keywords
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
Medical subject headings
Head and Neck Neoplasms, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionApr 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017498
Sponsor's protocol ID
EORTC-24982
Other IDs
EORTC-24982
Status last verified
Sep 2012
First submitted
6 Jun 2001
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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 Nov;44(17):2542-5. doi: 10.1016/j.ejca.2008.08.014. Epub 2008 Sep 24.

    PubMed 18819792

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00017498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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