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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No