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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-U99-1 | |||
| EU-20030 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug |
DISEASE CHARACTERISTICS:
Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
Measurable disease by CT or MRI scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Maulard-Durdux, MD | Hopital Tenon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Drevon | Dijon | 21000 | France | |||
| CHR de Grenoble - La Tronche |
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| Grenoble |
| 38043 |
| France |
| Hopital Perpetuel Secours | Levallois-Perret | 92300 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 57038 | France |
| Hopital Laennec | Paris | 75007 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Tenon | Paris | 75970 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| C.H. Senlis | Senlis | 60309 | France |
| Centre Hospitalier Regional Metz Thionville | Thionville | 57126 | France |
| Centre Hospitalier Princesse Grace | Monte Carlo | 98000 | Monaco |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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