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| Sponsor: | 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 tartrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 | |
| Hopital Saint-Louis | |
| Amiens, France, 80054 Cedex 1 | |
| Hopital Gouin | |
| Clichy, France, 92110 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre Hospitalier Intercommunal Toulon - La Seyne/Mer | |
| Toulon - Cedex, France, 83056 | |
| Study Chair: | Jean-Louis Wendling, MD | Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer |
More Information
| ClinicalTrials.gov Identifier: | NCT00006114 History of Changes |
| Other Study ID Numbers: | CDR0000068126, FRE-GERCOR-NONA-U98-1, EU-20025 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones Vinorelbine Mitoxantrone Vinblastine Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |