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Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: September 13, 2001   Last Updated: November 7, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024167
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: estramustine phosphate sodium
Drug: ketoconazole
Drug: prednisone
Drug: vinblastine
Radiation: strontium chloride Sr 89
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Stronium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: October 2001
Estimated Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Induction regimen A: Experimental
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. Treatment repeats every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive oral ketoconazole three times daily until disease progression
Drug: doxorubicin hydrochloride
Given IV
Drug: estramustine phosphate sodium
Given orally
Drug: ketoconazole
Given orally
Drug: vinblastine
Given IV
Induction regimen B: Experimental
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.
Drug: docetaxel
Given IV
Drug: prednisone
Given orally
Consolidation arm I: Experimental
Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.
Drug: doxorubicin hydrochloride
Given IV
Radiation: strontium chloride Sr 89
Given IV
Consolidation arm II: Experimental
Patients receive doxorubicin as in consolidation arm I.
Drug: doxorubicin hydrochloride
Given IV

Detailed 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), 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024167

  Hide Study Locations
Locations
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Richard J. LoCicero, MD     770-297-5700        
United States, Illinois
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Christopher G. Rose, MD     847-965-3200        
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent     815-489-4413        
Veterans Affairs Medical Center - Hines Recruiting
Hines, Illinois, United States, 60141
Contact: Nirmala Bhoopalam, MD     708-202-2782        
United States, Iowa
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Hematology Oncology Associates of the Quad Cities Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Shobha R. Chitneni, MD, MBBS     563-355-7733        
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Genesis Regional Cancer Center at Genesis Medical Center Recruiting
Davenport, Iowa, United States, 52803
Contact: George Kovach, MD     563-421-1960        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Ralph B. Vance     601-984-5590        
United States, Montana
Big Sky Oncology Recruiting
Great Falls, Montana, United States, 59405-5309
Contact: Clinical Trail Office - Big Sky Oncology     406-731-8217        
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD     406-238-6290        
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Community Medical Center Recruiting
Missoula, Montana, United States, 59801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Guardian Oncology and Center for Wellness Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello, MD     406-238-6290        
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick     406-329-7029        
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana     406-238-6962        
Northern Rockies Radiation Oncology Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Grant W. Harrer, MD, FACP, CCTI     406-731-8100        
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital Recruiting
Kearney, Nebraska, United States, 68848-1990
Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good     308-865-7963        
United States, North Carolina
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200ext.201        
Southeastern Medical Oncology Center - Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD     330-375-3557        
Cancer Care Center, Incorporated Recruiting
Salem, Ohio, United States, 44460
Contact: William F. Demas, MD     330-375-3557        
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center     330-375-4221        
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
United States, South Carolina
McLeod Regional Medical Center Recruiting
Florence, South Carolina, United States, 29501
Contact: Clinical Trials Office - McLeod Regional Medical Center     843-679-7256        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Barry C. Mirtsching, MD     972-566-5588        
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Shi-Ming Tu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: University of Texas M.D. Anderson CCOP Research Base ( Michael J. Fisch )
Study ID Numbers: CDR0000068897, MDA-ID-00156, NCI-3410
Study First Received: September 13, 2001
Last Updated: November 7, 2009
ClinicalTrials.gov Identifier: NCT00024167     History of Changes
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Estramustine
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Urogenital Neoplasms
Antibiotics, Antineoplastic
Hormones
Docetaxel
Neoplasms by Site
Therapeutic Uses
Antifungal Agents
Alkylating Agents
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Ketoconazole
Genital Diseases, Male
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Neoplasms
Tubulin Modulators
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 25, 2009