First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
18 Years
80 Years
Male
Prostate Cancer
Trial Information
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma
of the prostate
- Progressive disease despite hormonal therapy or orchiectomy
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 9 g/dL
Hepatic:
- Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone
metastasis)
- Bilirubin less than 2 times ULN
Renal:
- Creatinine less than 2 times ULN
Cardiovascular:
- Adequate cardiac function
Other:
- No other prior malignancy except curatively treated basal or squamous cell skin
cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Prior corticosteroids allowed if started at least 8 weeks prior to study
Radiotherapy:
- At least 8 weeks since prior extensive radiotherapy
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jean-Louis Wendling, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Authority:
United States: Federal Government
Study ID:
CDR0000068126
NCT ID:
NCT00006114
Start Date:
May 1999
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IV prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
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