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Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer 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 Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer Clinical research trials and Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer 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 Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer. Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer 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 Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer clinical trial. Participants frequently get the best healthcare available for their Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer 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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Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer



Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

For Condition: stage 4 bladder cancer,stage 3 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.
Details: OBJECTIVES: - Determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder. - Determine the progression free survival of these patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder - Measurable disease by CT or MRI scan - Greater than 10 mm PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Not specified Renal: - Creatinine less than 1.36 mg/dL Cardiovascular: - No uncontrolled cardiac disease - No severe cardiac arrhythmias Other: - Not pregnant or nursing - No other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior intravesical immunotherapy for superficial disease allowed - No prior systemic biologic response modifier therapy for advanced disease Chemotherapy: - Prior intravesical chemotherapy for superficial disease allowed - No prior systemic chemotherapy for advanced disease Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy allowed Surgery: - No prior surgery
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CatherineDurdux,  Study Chair,  Hopital Tenon

Centre Hospitalier Regional Metz Thionville
Thionville,  ,  57126
France
 

Centre Hospitalier Princesse Grace
Monte Carlo,  ,  98000
Monaco
 

Hopital Notre-Dame de Bon Secours
Metz,  ,  57038
France
 

Hopital Tenon
Paris,  ,  75970
France
 

Hopital Laennec
Paris,  ,  75007
France
 

Hopital Drevon
Dijon,  ,  21000
France
 

Polyclinique De Courlancy
Reims,  ,  F-51100
France
 

CHR de Grenoble - La Tronche
Grenoble,  ,  38043
France
 

C.H. Senlis
Senlis,  ,  60309
France
 

Hopital Perpetuel Secours
Levallois-Perret,  ,  92300
France
 

Hopital Saint Antoine
Paris,  ,  75571
France
 

CHU de la Timone
Marseille,  ,  13385
France
 


Additional Information:
Study ID Numbers:
  CDR0000068131;  FRE-GERCOR-U99-1,EU-20030
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006118

Other Stage 4 Bladder Cancer Studies:
1. ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract

2. R115777 in Treating Patients With Advanced Bladder Cancer

3. Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

4. Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer

5. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer

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