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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-NONA-U98-1 | |||
| EU-20025 |
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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 combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitoxantrone hydrochloride | Drug | |||
| vinorelbine tartrate | Drug |
DISEASE CHARACTERISTICS:
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 |
|---|---|---|
| Jean-Louis Wendling, MD | Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint-Louis | Amiens | 80054 Cedex 1 | France | |||
| Hopital Gouin |
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| Clichy |
| 92110 |
| France |
| Hopital Perpetuel Secours | Levallois-Perret | 92300 | France |
| CHU de la Timone | Marseille | 13385 | 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 Intercommunal Toulon - La Seyne/Mer | Toulon | 83056 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008942 | Mitoxantrone |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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