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Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck Clinical research trials and Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck. Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck clinical trial. Participants frequently get the best healthcare available for their Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck  Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
For Condition: stage 4 salivary gland cancer,stage 4 adenoid cystic carcinoma of the oral cavity,salivary gland adenoid cystic carcinoma,recurrent adenoid cystic carcinoma of the oral cavity,recurrent salivary gland cancer
Status: No longer recruiting
Sponsor(s): EORTC Head and Neck Cancer Cooperative Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Pieterde Mulder, , University Medical Center Nijmegen
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, , 20133
Italy
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Institut Jules Bordet
Brussels, , 1000
Belgium
Vrije Universiteit Medisch Centrum
Amsterdam, , 1007 MB
Netherlands
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Ospedale Santa Croce
Cuneo, , 12100
Italy
Additional Information:
Study ID Numbers: CDR0000068697; EORTC-24982
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017498
Other Salivary Gland Adenoid Cystic Carcinoma Studies:
1. Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
2. Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
3. Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Related Studies:
Other salivary gland adenoid cystic carcinoma Clinical Trials
Other Clinical Trials
Other Milan Clinical Trials
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
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