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

First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006118

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-07-31

Completion date

Unknown

Last updated

2008-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder

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.

Interventions

DRUGcisplatin

DRUGgemcitabine hydrochloride

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Countries

France, Monaco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026