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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Drevon
  • CHR de Grenoble - La Tronche
  • Hopital Perpetuel Secours
  • CHU de la Timone
  • Hopital Notre-Dame de Bon Secours
  • Hopital Laennec
  • Hopital Saint Antoine
  • Hopital Tenon
  • Polyclinique De Courlancy
  • C.H. Senlis
  • Centre Hospitalier Regional Metz Thionville
  • Centre Hospitalier Princesse Grace

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006118
Brief Title
Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Official Title
First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Unknown status
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Maulard-Durdux, MD
Organizational Affiliation
Hopital Tenon
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Hopital Laennec
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Centre Hospitalier Princesse Grace
City
Monte Carlo
ZIP/Postal Code
98000
Country
Monaco

12. IPD Sharing Statement

Learn more about this trial

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

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