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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Prostate Cancer

Trial Information

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether chemotherapy is more effective with or without strontium-89 in treating bone metastases.

PURPOSE: This randomized phase III trial is studying giving chemotherapy together with strontium-89 to see how well it works compared to chemotherapy alone in treating patients with prostate cancer that has spread to the bone.

DISEASE CHARACTERISTICS:

• Diagnosis of adenocarcinoma of the prostate
• No small cell carcinoma
• Androgen-independent
• No evidence of response after either of the following anti-androgen withdrawal periods:
  • Within 4 weeks for flutamide
  • Within 6 weeks for bicalutamide or nilutamide
  • Rising prostate-specific antigen (PSA) (at least 5 ng/mL) on at least 2 occasions at least 1 week apart AND bone pain OR worsening bone scan with new lesions in less than 6 months
  • Castrate testosterone level no greater than 50 ng/mL (must continue treatment to maintain castrate levels)
  • No symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria)
  • Osteoblastic metastases on bone scan or CT scan
  • No predominant visceral metastases to liver, lungs, or brain

PATIENT CHARACTERISTICS:

• Age: Any age
• Performance status:Zubrod 0-3
• Life expectancy: At least 12 weeks
• Hematopoietic: WBC greater than 3,000/mm^3
  Absolute neutrophil count greater than 1,500/mm^3
  Platelet count greater than 100,000/mm^3
• Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN
• Renal: Not specified
• Cardiovascular: No transient ischemic attack or myocardial infarction within the past 12 months
  No active angina or claudication sufficient to limit activity
  No symptomatic congestive heart failure
  No unstable angina pectoris
  No cardiac arrhythmia
• Other: Fertile patients must use effective contraception
  No prior allergic reaction to compounds of similar biologic or chemical composition to study drugs
  No other conditions (e.g., pernicious anemia) associated with achlorhydria
  No other active malignancy or malignancy that is likely to become active except non-melanoma skin cancer
  No ongoing or active infection
  No psychiatric illness or social situation that would preclude study participation
  No other uncontrolled concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

• Biologic therapy: At least 4 weeks since prior immunotherapy and recovered
  Prior angiogenesis inhibitors and gene therapy allowed
• Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  No prior doxorubicin or vinblastine for patients receiving induction chemotherapy with KAVE (ketoconazole, doxorubicin, vinblastine, estramustine)
  No prior docetaxel for patients receiving induction chemotherapy with prednisone plus docetaxel
• Endocrine therapy: See Disease Characteristics
  Prior secondary hormonal agents (e.g., aminoglutethimide, diethylstilbestrol, or estramustine) allowed
  Prior steroid therapy (e.g., dexamethasone, prednisone, or hydrocortisone) allowed
• Radiotherapy: At least 4 weeks since prior radiotherapy and recovered
  No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
• Surgery: No prior vagotomy
• Other: No more than 1 prior cytotoxic regimen

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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