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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.
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes
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 Paclitaxel Gemcitabine Gemcitabine hydrochloride
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

Additional Information:
No publications provided

Study ID Numbers: CDR0000068131, FRE-GERCOR-U99-1, EU-20030
Study First Received: August 3, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006118     History of Changes
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:
Antimetabolites
Urinary Tract Neoplasm
Cystocele
Immunologic Factors
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Antimitotic Agents
Carcinoma, Transitional Cell
Urologic Neoplasms
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Cisplatin
Urologic Diseases
Paclitaxel
Tubulin Modulators
Bladder Neoplasm
Gemcitabine
Antineoplastic Agents, Phytogenic
Transitional Cell Carcinoma

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

ClinicalTrials.gov processed this record on May 06, 2009