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Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
mitoxantrone hydrochloride
vinorelbine tartrate
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint-Louis
  • Hopital Gouin
  • Hopital Perpetuel Secours
  • CHU de la Timone
  • Hopital Laennec
  • Hopital Saint Antoine
  • Hopital Tenon
  • Polyclinique De Courlancy
  • C.H. Senlis
  • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
February 26, 2011
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006114
Brief Title
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2000
Overall Recruitment Status
Unknown status
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Wendling, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Saint-Louis
City
Amiens
ZIP/Postal Code
80054 Cedex 1
Country
France
Facility Name
Hopital Gouin
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Laennec
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
City
Toulon - Cedex
ZIP/Postal Code
83056
Country
France

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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