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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Ospedale Santa Croce
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Vrije Universiteit Medisch Centrum
  • University Medical Center Nijmegen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00017498
Brief Title
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Official Title
Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter H. M. de Mulder, MD, PhD
Organizational Affiliation
Universitair Medisch Centrum St. Radboud - Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18819792
Citation
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.
Results Reference
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Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

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