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

Stopped early · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00024167

Run by

M.D. Anderson Cancer Center

People needed

265

Starts

2002-04-01

Last updated by the study team

2016-03-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• 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
• 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

Where it is running

• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center — Savannah, Georgia, United States
• Veterans Affairs Medical Center - Hines — Hines, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Hematology Oncology Associates of the Quad Cities — Bettendorf, Iowa, United States
• Genesis Regional Cancer Center at Genesis Medical Center — Davenport, Iowa, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
• St. Luke's Regional Medical Center — Sioux City, Iowa, United States
• University of Mississippi Cancer Clinic — Jackson, Mississippi, United States
• CCOP - Montana Cancer Consortium — Billings, Montana, United States
• Hematology-Oncology Centers of the Northern Rockies - Billings — Billings, Montana, United States
• Northern Rockies Radiation Oncology Center — Billings, Montana, United States
• St. Vincent Healthcare Cancer Care Services — Billings, Montana, United States
• Billings Clinic - Downtown — Billings, Montana, United States
• Bozeman Deaconess Cancer Center — Bozeman, Montana, United States
• St. James Healthcare Cancer Care — Butte, Montana, United States
• Big Sky Oncology — Great Falls, Montana, United States
• Great Falls Clinic - Main Facility — Great Falls, Montana, United States
• Sletten Cancer Institute at Benefis Healthcare — Great Falls, Montana, United States
• Study site — Great Falls, Montana, United States
• St. Peter's Hospital — Helena, Montana, United States
• Glacier Oncology, PLLC — Kalispell, Montana, United States
• Kalispell Medical Oncology at KRMC — Kalispell, Montana, United States
• Kalispell Regional Medical Center — Kalispell, Montana, United States

Full record on ClinicalTrials.gov

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