Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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.
Drug: mitoxantrone hydrochloride
Drug: vinorelbine tartrate
|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|
- Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
- Determine the toxicities of this treatment regimen in these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006114
|Amiens, France, 80054 Cedex 1|
|Clichy, France, 92110|
|Hopital Perpetuel Secours|
|Levallois-Perret, France, 92300|
|CHU de la Timone|
|Marseille, France, 13385|
|Paris, France, 75007|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|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|