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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006118
First Posted: January 27, 2003
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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 2

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006118


Locations
France
Hopital Drevon
Dijon, France, 21000
CHR de Grenoble - La Tronche
Grenoble, France, 38043
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
CHU de la Timone
Marseille, France, 13385
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Laennec
Paris, France, 75007
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Centre Hospitalier Regional Metz Thionville
Thionville, France, 57126
Monaco
Centre Hospitalier Princesse Grace
Monte Carlo, Monaco, 98000
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Study Chair: Catherine Maulard-Durdux, MD Hopital Tenon
  More Information

ClinicalTrials.gov Identifier: NCT00006118     History of Changes
Other Study ID Numbers: CDR0000068131
FRE-GERCOR-U99-1
EU-20030
First Submitted: August 3, 2000
First Posted: January 27, 2003
Last Update Posted: July 24, 2008
Last Verified: November 2001

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

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