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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017498 |
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 II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders Tonsils and Adenoids |
| Drug Information available for: | Gemcitabine hydrochloride Gemcitabine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck |
| Study Start Date: | February 2001 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other prior or concurrent malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |||||
| Institut Jules Bordet | |||||
| Brussels, Belgium, 1000 | |||||
| U.Z. Gasthuisberg | |||||
| Leuven, Belgium, B-3000 | |||||
| Universitair Ziekenhuis Antwerpen | |||||
| Edegem, Belgium, B-2650 | |||||
| Italy | |||||
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |||||
| Milan, Italy, 20133 | |||||
| Ospedale Santa Croce | |||||
| Cuneo, Italy, 12100 | |||||
| Netherlands | |||||
| University Medical Center Nijmegen | |||||
| Nijmegen, Netherlands, NL-6500 HB | |||||
| Vrije Universiteit Medisch Centrum | |||||
| Amsterdam, Netherlands, 1007 MB | |||||
| European Organization for Research and Treatment of Cancer |
| Investigator: | Pieter H. M. de Mulder, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068697, EORTC-24982 |
| First Received: | June 6, 2001 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017498 |
| Health Authority: | United States: Federal Government |
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