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

This study is ongoing, but not recruiting participants.

Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006118
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

Drug Information available for:   Cisplatin    Gemcitabine hydrochloride    Gemcitabine    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

Detailed Description:

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
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006118

Locations
France
C.H. Senlis    
      Senlis, France, 60309
Centre Hospitalier Regional Metz Thionville    
      Thionville, France, 57126
CHR de Grenoble - La Tronche    
      Grenoble, France, 38043
Hopital Laennec    
      Paris, France, 75007
Hopital Drevon    
      Dijon, France, 21000
CHU de la Timone    
      Marseille, France, 13385
Hopital Notre-Dame de Bon Secours    
      Metz, France, 57038
Hopital Perpetuel Secours    
      Levallois-Perret, France, 92300
Hopital Saint Antoine    
      Paris, France, 75571
Hopital Tenon    
      Paris, France, 75970
Polyclinique De Courlancy    
      Reims, France, F-51100
Monaco
Centre Hospitalier Princesse Grace    
      Monte Carlo, Monaco, 98000

Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators
Study Chair:     Catherine Maulard-Durdux, MD     Hopital Tenon    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068131, FRE-GERCOR-U99-1, EU-20030
First Received:   August 3, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006118
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer  
stage IV bladder cancer  
transitional cell carcinoma of the bladder  

Study placed in the following topic categories:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Carcinoma
Urologic Diseases
Cisplatin
Paclitaxel
Gemcitabine
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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