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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003682 |
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 |
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Prostate Cancer |
Drug: doxorubicin hydrochloride Drug: methylprednisolone |
Phase III |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | October 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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 |
Study Chair: | Stephane Culine, MD | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
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 |
stage IV prostate cancer recurrent prostate cancer |
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 |
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 |