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

Last updated: February 19, 2016
Sponsor: M.D. Anderson Cancer Center
Overall Status: Terminated

Phase

3

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT00024167
ID00-156
P30CA016672
CDR0000068897
U10CA045809
NCI-2009-00009
NCI-3410
MDA-ID-00156
  • Ages > 18
  • Male

Study 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

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 worseningbone scan with new lesions over a period of <6 months

  2. Patients on antiandrogens should be discontinued from flutamide or nilutamide for atleast 4 weeks and bicalutamide for 6 weeks; If progression is documented during thistime 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 oftestosterone 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: Leukocytesgreater than 3,000/mcL Absolute neutrophil count greater than 1,500/mcL Plateletsgreater than 100,000/mcL Total bilirubin less than or equal to 2X institutional upperlimit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2X institutional upper limitof normal

  10. The patient must have the ability to understand and the willingness to sign a writteninformed consent document

  11. Participating subjects and their female partners agree to the use of adequatecontraception (hormonal or barrier method of birth control) prior to study entry andfor the duration of study participation

Exclusion

Exclusion Criteria:

  1. History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to the agents used on this trial

  2. Prior doxorubicin, or vinblastine in the KAVE arm and prior docetaxel in theprednisone plus docetaxel arm. However, previous treatment using other secondaryhormonal agents (aminoglutethimide, diethylstilbesterol, estramustine), steroids (dexamethasone, prednisone, hydrocortisone), angiogenesis inhibitors, gene therapy, orimmunotherapy 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 (6weeks for nitrosoureas or mitomycin C) prior to entering the study or those who havenot recovered from adverse events due to agents administered more than 4 weeks earlier

  6. Previous vagotomy or other conditions (such as pernicious anemia) associated withachlorhydria. Patients with active peptic ulcer disease who still require regular useof 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 besuitable for randomization

  7. Predominant visceral metastases in the liver, lungs, or brain

  8. Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasivedisease (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 skincancer)

  12. Uncontrolled inter-current illness: including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements

Study Design

Total Participants: 265
Study Start date:
April 01, 2002
Estimated Completion Date:

Study Description

OBJECTIVES:

  • Compare the effectiveness, in terms of overall survival, of consolidation therapy with or without strontium chloride Sr 89 after induction chemotherapy in patients with androgen-independent prostate cancer.

OUTLINE: This is a randomized study. Patients are stratified according to type of induction chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20 vs more than 20), Eastern Cooperative Oncology (ECOG) performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).

  • Induction therapy: Patients receive 1 of 2 induction therapy regimens.

    • Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8. Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients continue to receive oral ketoconazole three times daily until disease progression.

  • Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity.

    • Consolidation therapy: Patients with a prostate-specific antigen (PSA) response (at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA levels decreased at least 50% from baseline) are randomized to 1 of 2 consolidation treatment arms.

  • Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.

  • Arm II: Patients receive doxorubicin as in arm I. Patients are followed every 4 weeks until PSA progression and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this study within 48 months.

Connect with a study center

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia 31403-3089
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois 60141
    United States

    Site Not Available

  • Swedish-American Regional Cancer Center

    Rockford, Illinois 61104-2315
    United States

    Site Not Available

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa 52722
    United States

    Site Not Available

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa 52803
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Billings Clinic - Downtown

    Billings, Montana 59107-7000
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana 59101
    United States

    Site Not Available

  • Northern Rockies Radiation Oncology Center

    Billings, Montana 59101
    United States

    Site Not Available

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana 59101
    United States

    Site Not Available

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana 59715
    United States

    Site Not Available

  • St. James Healthcare Cancer Care

    Butte, Montana 59701
    United States

    Site Not Available

  • Big Sky Oncology

    Great Falls, Montana 59405-5309
    United States

    Site Not Available

  • Great Falls Clinic - Main Facility

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Great Falls, Montana 59405
    United States

    Site Not Available

  • St. Peter's Hospital

    Helena, Montana 59601
    United States

    Site Not Available

  • Glacier Oncology, PLLC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Regional Medical Center

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Community Medical Center

    Missoula, Montana 59801
    United States

    Site Not Available

  • Guardian Oncology and Center for Wellness

    Missoula, Montana 59804
    United States

    Site Not Available

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana 59807
    United States

    Site Not Available

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana 59807-7877
    United States

    Site Not Available

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska 68848-1990
    United States

    Site Not Available

  • Kinston Medical Specialists

    Kinston, North Carolina 28501
    United States

    Site Not Available

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio 44309-2090
    United States

    Site Not Available

  • Barberton Citizens Hospital

    Barberton, Ohio 44203
    United States

    Site Not Available

  • Cancer Care Center, Incorporated

    Salem, Ohio 44460
    United States

    Site Not Available

  • Cancer Treatment Center

    Wooster, Ohio 44691
    United States

    Site Not Available

  • McLeod Regional Medical Center

    Florence, South Carolina 29501
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Medical City Dallas Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming 82801
    United States

    Site Not Available

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