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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy  Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jean-LouisWendling, Study Chair, Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon - Cedex, , 83056
France
Hopital Tenon
Paris, , 75970
France
Hopital Gouin
Clichy, , 92110
France
Hopital Perpetuel Secours
Levallois-Perret, , 92300
France
Polyclinique De Courlancy
Reims, , F-51100
France
C.H. Senlis
Senlis, , 60309
France
CHU de la Timone
Marseille, , 13385
France
Hopital Saint Antoine
Paris, , 75571
France
Hopital Saint-Louis
Amiens, , 80054 Cedex 1
France
Hopital Laennec
Paris, , 75007
France
Additional Information:
Study ID Numbers: CDR0000068126; EU-20025,FRE-GERCOR-NONA-U98-1
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006114
Other Stage 4 Prostate Cancer Studies:
1. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
2. Paclitaxel, Estramustine, and Thalidomide in Treating Patients With Progressive Metastatic Androgen-Independent Prostate Cancer
3. Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
4. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
5. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Clinical Trials
Other Senlis Clinical Trials
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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