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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003682
• Other study ID #: CDR0000066784
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Terminated
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 22, 2016
• Start date: October 1998
• Est. completion date: March 2001

Study information

• Verified date: June 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: March 2001
• Est. primary completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• doxorubicin hydrochloride

• methylprednisolone

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	Centre Leon Berard	Lyon
France	Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	C.H.U. - Hopital Gaston Doumergue	Nimes
France	Hotel Dieu de Paris	Paris
France	Institut Mutualiste Montsouris	Paris
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier General de Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France,