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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017498 |
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 |
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.
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:
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 |
Investigator: | Pieter H. M. de Mulder, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Study ID Numbers: | CDR0000068697, EORTC-24982 |
Study First Received: | June 6, 2001 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00017498 |
Health Authority: | United States: Federal Government |
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 |
Carcinoma, Adenoid Cystic Head and Neck Neoplasms Gemcitabine Adenocarcinoma Salivary Gland Diseases |
Adenoid cystic carcinoma Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |