Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Doxorubicin hydrochloride; Estramustine phosphate sodium; Ketoconazole; Prednisone; Vinblastine; Strontium chloride Sr 89; Dexamethasone
Intervention description: 75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.; 20 mg/m2 IV, day 1 on Weeks 1, 3, 5; 140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6; 400 mg orally (po) 3 x day, Days 1 through 7; 5 mg orally 2 x daily, weeks 1-14; 4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6; One dose (4 mCi total dose) IV; 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
Intervention MeSH terms: Ketoconazole; Dexamethasone; Prednisone; Estramustine; Docetaxel; Doxorubicin; Liposomal doxorubicin; Vinblastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 265.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer; Strontium-89; Induction Chemotherapy; Androgen-Independent Prostate Cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Rising PSA on at least 2 occasions >1 week apart (minimum value of 5 ng/ml),
             accompanied either by bone pain or, if the patient is asymptomatic, by a worsening
             bone scan with new lesions over a period of <6 months

          2. Patients on antiandrogens should be discontinued from flutamide or nilutamide for at
             least 4 weeks and bicalutamide for 6 weeks; If progression is documented during this
             time interval as in inclusion criterion # 1, patients are eligible

          3. Osteoblastic metastases on bone scan or CT scan

          4. Androgen-independent prostate adenocarcinoma

          5. Castrate testosterone level </= 50 ng/ml; treatment to maintain castrate levels of
             testosterone must be continued

          6. >/= 18 years of age

          7. Life expectancy of greater than or equal to 12 weeks

          8. Zubrod performance status </= 3

          9. Patients must have normal organ and marrow function as defined below: Leukocytes
             greater than 3,000/mcL Absolute neutrophil count greater than 1,500/mcL Platelets
             greater than 100,000/mcL Total bilirubin less than or equal to 2X institutional upper
             limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2X institutional upper limit
             of normal

         10. The patient must have the ability to understand and the willingness to sign a written
             informed consent document

         11. Participating subjects and their female partners agree to the use of adequate
             contraception (hormonal or barrier method of birth control) prior to study entry and
             for the duration of study participation

        Exclusion Criteria:

          1. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the agents used on this trial

          2. Prior doxorubicin, or vinblastine in the KAVE arm and prior docetaxel in the
             prednisone plus docetaxel arm. However, previous treatment using other secondary
             hormonal agents (aminoglutethimide, diethylstilbesterol, estramustine), steroids
             (dexamethasone, prednisone, hydrocortisone), angiogenesis inhibitors, gene therapy, or
             immunotherapy are allowed

          3. More than one prior cytotoxic treatment

          4. Prior Sr-89 or Sm-153 treatment

          5. Patients who have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6
             weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
             not recovered from adverse events due to agents administered more than 4 weeks earlier

          6. Previous vagotomy or other conditions (such as pernicious anemia) associated with
             achlorhydria. Patients with active peptic ulcer disease who still require regular use
             of H2 blockers (such as cimetidine [Tagamet], ranitidine [Zantac], famotidine
             [Pepcid], etc), proton pump inhibitors (omeprazole [Prilosec]), or antacids (Mylanta,
             Maalox, Tums, etc) at week 16 of induction chemotherapy (option 1 only) might not be
             suitable for randomization

          7. Predominant visceral metastases in the liver, lungs, or brain

          8. Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive
             disease (hematuria)

          9. Small cell carcinoma

         10. Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI)
             within 12 months, or active angina or claudication sufficient to limit activity

         11. Active or likely to become active second malignancy (other than non-melanoma skin
             cancer)

         12. Uncontrolled inter-current illness: including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements