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| ID | Type | Description | Link |
|---|---|---|---|
| GETUG- P02 | |||
| INCA-RECF0422 | |||
| EUDRACT-2006-001597-25 |
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RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.
PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoposide | Drug | |||
| mitoxantrone hydrochloride | Drug | |||
| prednisone | Drug | |||
| vinorelbine tartrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Palliative response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of palliative response | ||
| Biological response | ||
| Tumor response as assessed by RECIST criteria |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Metastatic progressive disease meeting the following criteria:
Received docetaxel as first-line chemotherapy
Received at least 1 prior regimen of hormone therapy
Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
No symptomatic or evolutionary CNS disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Joly, MD, PhD | Centre Francois Baclesse | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Regional Francois Baclesse | Caen | 14076 | France |
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| Time to progression |
| Overall survival |
| Quality of life as assessed by QLQ-PR25 |
| Impact on autonomy in patients > 70 years of age |
| Toxicity |
| 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 |
|---|---|
| D005047 | Etoposide |
| D008942 | Mitoxantrone |
| D011241 | Prednisone |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring 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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