NCT00017498

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.2 years

First QC Date

June 6, 2001

Last Update Submit

September 20, 2012

Conditions

Head and Neck Cancer

Keywords

stage IV salivary gland cancerrecurrent salivary gland cancersalivary gland adenoid cystic carcinomastage IV adenoid cystic carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavity

Interventions

gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 18819792RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Pieter H. M. de Mulder, MD, PhD

    Universitair Medisch Centrum St. Radboud - Nijmegen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

April 1, 2003

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

BE(3)IT(2)NL(2)