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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006118
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: November 2001
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Catherine Maulard-Durdux, MD Hopital Tenon
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006118     History of Changes
Other Study ID Numbers: CDR0000068131, FRE-GERCOR-U99-1, EU-20030
Study First Received: August 3, 2000
Last Updated: July 23, 2008
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

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

ClinicalTrials.gov processed this record on September 11, 2014