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SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract Clinical research trials and SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract  SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
For Condition: recurrent urethral cancer,recurrent transitional cell cancer of the renal pelvis and ureter,stage 4 bladder cancer,anterior urethral cancer,recurrent bladder cancer,metastatic transitional cell cancer of the renal pelvis and ureter,posterior urethral cancer,urethral cancer associated with invasive bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group , EORTC Genito-Urinary Tract Cancer Cooperative Group,EORTC Pharmacology and Molecular Mechanisms Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.
Details: OBJECTIVES: - Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract. - Determine the time to progression and objective response rate of this treatment regimen in these patients. - Assess the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336 twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent courses). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 7-31 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 unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis - At least one measurable lesion - 20 mm or greater by conventional techniques OR - 10 mm or greater by spiral CT scan - Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease - No clinical signs of brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases) Renal: - Creatinine no greater than 1.7 mg/dL Cardiovascular: - Normal cardiac function - No ischemic heart disease within the past 6 months - Normal 12 lead ECG Other: - No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336 - No unstable systemic disease - No active uncontrolled infection - No psychological, familial, sociological, or geographical condition that would preclude study - No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No prior farnesyl protein transferase inhibitors or gemcitabine Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - At least 2 weeks since prior major surgery Other: - No other concurrent anticancer agents - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldWit, Study Chair, Rotterdam Cancer Institute
University Medical Center Nijmegen
Nijmegen, , 6500
Netherlands
Additional Information:
Study ID Numbers: CDR0000068217; EORTC-16997,EORTC-PAMM-16997,EORTC-GU-16997
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006351
Other Urethral Cancer Associated With Invasive Bladder Cancer Studies:
1. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
2. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
3. Combination Chemotherapy in Treating Patients With Bladder Cancer
4. Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
5. Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
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SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
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