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Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
doxorubicin hydrochloride
methylprednisolone
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven, symptomatic prostate cancer Appearance or aggravation of clinical symptoms with progression of disease Bone pain OR Urethral compression OR 20% decrease in performance status Metastatic disease Local-regional or distant secondary tumors Documented radiologically or scintigraphically Hormone-refractory as defined by progression while on hormone treatment (simple castration or complete androgen blockage) Progressive disease No urethral or cervical stenosis Increase of greater than 25% prostatic volume on endorectal echography No documentation by PSA increase or imagery only Hormone castration verified by testosterone less than 0.5 ng/mL No history of CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: No specified Hematopoietic: Neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Ventricular ejection fraction at least 50% Other: No contraindication to anthracycline treatment No prior primary cancer except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Arm I: No concurrent chemotherapy Endocrine therapy: At least 1 month since prior hormone therapy, including estramustine, except LHRH agonists, which continue Arm I: No concurrent estramustine Radiotherapy: At least 3 months since prior strontium 89 No concurrent strontium Surgery: See Disease Characteristics

Sites / Locations

  • Institut Sainte Catherine
  • Centre de Lute Contre le Cancer,Georges-Francois Leclerc
  • Centre Leon Berard
  • Institut J. Paoli and I. Calmettes
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • CRLCC Nantes - Atlantique
  • Centre Antoine Lacassagne
  • C.H.U. - Hopital Gaston Doumergue
  • Institut Mutualiste Montsouris
  • Hotel Dieu de Paris
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Centre Hospitalier General de Saint Nazaire

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 22, 2016
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00003682
Brief Title
Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer
Official Title
Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusions
Study Start Date
October 1998 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UNICANCER

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the contribution of this treatment on control of pain in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the objective response and biological observations in these patients after this treatment. V. Determine the effect of this regimen on survival of these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II: Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of life is assessed before treatment, every 4 weeks during treatment, and then every 3 months. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
methylprednisolone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven, symptomatic prostate cancer Appearance or aggravation of clinical symptoms with progression of disease Bone pain OR Urethral compression OR 20% decrease in performance status Metastatic disease Local-regional or distant secondary tumors Documented radiologically or scintigraphically Hormone-refractory as defined by progression while on hormone treatment (simple castration or complete androgen blockage) Progressive disease No urethral or cervical stenosis Increase of greater than 25% prostatic volume on endorectal echography No documentation by PSA increase or imagery only Hormone castration verified by testosterone less than 0.5 ng/mL No history of CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: No specified Hematopoietic: Neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Ventricular ejection fraction at least 50% Other: No contraindication to anthracycline treatment No prior primary cancer except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Arm I: No concurrent chemotherapy Endocrine therapy: At least 1 month since prior hormone therapy, including estramustine, except LHRH agonists, which continue Arm I: No concurrent estramustine Radiotherapy: At least 3 months since prior strontium 89 No concurrent strontium Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Culine, MD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
C.H.U. - Hopital Gaston Doumergue
City
Nimes
ZIP/Postal Code
30006
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Centre Hospitalier General de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France

12. IPD Sharing Statement

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Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

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