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Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003682
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: doxorubicin hydrochloride
Drug: methylprednisolone
Phase III

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Methylprednisolone Myocet
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 160
Study Start Date: October 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003682

Locations
France
C.H.U. - Hopital Gaston Doumergue
Nimes, France, 30006
Centre Antoine Lacassagne
Nice, France, 06189
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre Eugene Marquis
Rennes, France, 35064
Centre Henri Becquerel
Rouen, France, 76038
Centre Hospitalier General de Saint Nazaire
Saint Nazaire, France, 44600
Centre Leon Berard
Lyon, France, 69373
Institut Sainte Catherine
Avignon, France, 84082
Centre Rene Huguenin
Saint Cloud, France, 92211
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Hotel Dieu de Paris
Paris, France, 75181
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Institut Jean Godinot
Reims, France, 51056
Institut Mutualiste Montsouris
Paris, France, 75013
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators
Study Chair: Stephane Culine, MD Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066784, FRE-FNCLCC-GETUG-02, EU-98058
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003682     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Quality of Life
Methylprednisolone acetate
Urogenital Neoplasms
Prednisolone acetate
Genital Diseases, Male
Glucocorticoids
Neuroprotective Agents
Hormones
Recurrence
Doxorubicin
Anti-Bacterial Agents
Prednisolone
Peripheral Nervous System Agents
Prostatic Neoplasms
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prostatic Diseases
Genital Neoplasms, Male
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Urogenital Neoplasms
Antibiotics, Antineoplastic
Hormones
Neuroprotective Agents
Neoplasms by Site
Therapeutic Uses
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Genital Diseases, Male
Glucocorticoids
Protective Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Prostatic Neoplasms
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009