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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00081159 |
Purpose
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases.
PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.
| Condition | Intervention | Phase |
|
Metastatic Cancer Prostate Cancer |
Drug: doxorubicin hydrochloride Drug: goserelin Drug: leuprolide acetate Drug: strontium chloride Sr 89 Drug: zoledronic acid Procedure: orchiectomy |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Zoledronic acid Goserelin Leuprolide acetate Leuprolide Chlorides Strontium Strontium chloride Sr 89 Strontium chloride Sr 85 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase II Study Of Bone-Targeted Therapy In Advanced Androgen-Dependent Prostate Cancer |
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2004 |
OBJECTIVES:
Primary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the number of bony metastases (≤ 6 vs > 6). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 20 months.
Eligibility
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Androgen-dependent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Florida | |||||
| M.D. Anderson Cancer Center at Orlando | |||||
| Orlando, Florida, United States, 32806-2134 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Texas | |||||
| M.D. Anderson Cancer Center at University of Texas | |||||
| Houston, Texas, United States, 77030-4009 | |||||
| United States, Wisconsin | |||||
| CCOP - Marshfield Clinic Research Foundation | |||||
| Marshfield, Wisconsin, United States, 54449 | |||||
| M.D. Anderson Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Shi-Ming Tu, MD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000360625, MDA-2003-0922, NCI-6459 |
| First Received: | April 7, 2004 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00081159 |
| Health Authority: | United States: Federal Government |
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