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| Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006114 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: mitoxantrone hydrochloride Drug: vinorelbine ditartrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine |
| Study Start Date: | May 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| France | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre Hospitalier Intercommunal Toulon - La Seyne/Mer | |
| Toulon - Cedex, France, 83056 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Hopital Gouin | |
| Clichy, France, 92110 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Saint-Louis | |
| Amiens, France, 80054 Cedex 1 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Study Chair: | Jean-Louis Wendling, MD | Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer |
More Information
| Study ID Numbers: | CDR0000068126, FRE-GERCOR-NONA-U98-1, EU-20025 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006114 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Vinblastine Antimitotic Agents Genital Diseases, Male Hormones Recurrence |
Vinorelbine Tubulin Modulators Mitoxantrone Analgesics Peripheral Nervous System Agents Adenocarcinoma Antineoplastic Agents, Phytogenic Prostatic Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Urogenital Neoplasms Vinblastine Antimitotic Agents Genital Diseases, Male Pharmacologic Actions Neoplasms |
Neoplasms by Site Vinorelbine Sensory System Agents Therapeutic Uses Tubulin Modulators Peripheral Nervous System Agents Analgesics Mitoxantrone Antineoplastic Agents, Phytogenic Central Nervous System Agents Prostatic Neoplasms |