Study Stopped
Terminated due to slow accrual
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
7 other identifiers
interventional
265
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2001
CompletedStudy Start
First participant enrolled
April 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedResults Posted
Study results publicly available
March 22, 2016
CompletedMarch 22, 2016
February 1, 2016
12.4 years
September 13, 2001
January 22, 2016
February 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival From Randomization
Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.
Followed every 4 weeks from randomization until death, up to 7 years.
Secondary Outcomes (1)
Overall Survival From Registration
Followed every 4 weeks from registration until death, up to 7 years.
Study Arms (4)
Induction regimen A
EXPERIMENTALDoxorubicin IV over 24 hours day 1; Oral ketoconazole 3 x daily on days 1-7 of weeks 1, 3, and 5; Vinblastine IV over 30 minutes Day 1, oral Estramustine 3 x daily on Days 1-7 of weeks 2, 4, and 6.
Induction regimen B
EXPERIMENTALOral Prednisone 2 x daily on days 1-21 (days 1-14 of course 5 only) and Docetaxel IV over 1 hour Day 1.
Consolidation arm I
EXPERIMENTALDoxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
Consolidation arm II
EXPERIMENTALDoxorubicin as in Consolidation arm I.
Interventions
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
One dose (4 mCi total dose) IV
4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
Eligibility Criteria
You may qualify if:
- 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
- Osteoblastic metastases on bone scan or CT scan
- Androgen-independent prostate adenocarcinoma
- Castrate testosterone level \</= 50 ng/ml; treatment to maintain castrate levels of testosterone must be continued
- \>/= 18 years of age
- Life expectancy of greater than or equal to 12 weeks
- Zubrod performance status \</= 3
- 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
- The patient must have the ability to understand and the willingness to sign a written informed consent document
- 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
You may not qualify if:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial
- 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
- More than one prior cytotoxic treatment
- Prior Sr-89 or Sm-153 treatment
- 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
- 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
- Predominant visceral metastases in the liver, lungs, or brain
- Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria)
- Small cell carcinoma
- Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI) within 12 months, or active angina or claudication sufficient to limit activity
- Active or likely to become active second malignancy (other than non-melanoma skin cancer)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (40)
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, 60141, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Unknown Facility
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Cancer Care Center, Incorporated
Salem, Ohio, 44460, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
McLeod Regional Medical Center
Florence, South Carolina, 29501, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Tu SM, Kim J, Pagliaro LC, Vakar-Lopez F, Wong FC, Wen S, General R, Podoloff DA, Lin SH, Logothetis CJ. Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy. J Clin Oncol. 2005 Nov 1;23(31):7904-10. doi: 10.1200/JCO.2005.01.2310.
PMID: 16258090RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shi-Ming Tu, MD/Professor, Genitourinary Medical Oncology
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
Shi-Ming Tu, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2001
First Posted
January 27, 2003
Study Start
April 1, 2002
Primary Completion
September 1, 2014
Last Updated
March 22, 2016
Results First Posted
March 22, 2016
Record last verified: 2016-02