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Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer Clinical research trials and Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer. Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer  Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
For Condition: stage 1 bladder cancer,stage 0 bladder cancer,recurrent bladder cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of intravesical gemcitabine in patients with recurrent or refractory superficial bladder cancer. II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. III. Assess any responses in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive intravesical gemcitabine that is left in the bladder for 2 hours and then removed on day 1. Treatment continues every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage Tis, Ta, or T1 bladder carcinoma; No stage B1 disease or greater; No locally invasive or metastatic disease by CT or MRI; No upper urinary tract disease - Measurable persistent or recurrent superficial disease after standard treatment with intravesical BCG; Stage Tis disease must fail second course of BCG if complete response achieved with first course of BCG - Prior maximal transurethral resection; High-grade T1 or Tis disease must be ineligible for cystectomy --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 4 weeks since prior immunotherapy - Chemotherapy: Prior intravesical chemotherapy allowed; At least 4 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No prior radiotherapy to bladder - Surgery: See Disease Characteristics; At least 2 weeks since prior transurethral resection of the bladder/bladder biopsy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception for 1 week prior to, during, and for at least 2 weeks after study; No active bacterial infection requiring treatment with antibiotics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldTrump, Study Chair, University of Pittsburgh Cancer Institute
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000068527; PCI-IRB-990814,PCI-99039,LILLY-PCI-99039,NCI-G01-1926
Study Start Date: September 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014287
Other Recurrent Bladder Cancer Studies:
1. Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
2. Eflornithine in Treating Patients With Bladder Cancer
3. ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
4. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
5. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
Related Studies:
Other recurrent bladder cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
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