|
Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases Clinical research trials and Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases. Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases clinical trial. Subjects frequently get the best healthcare possible for their Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases  Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
For Condition: stage 4 prostate cancer,bone metastases,recurrent prostate cancer
Status: Not yet recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of combining hormone ablation therapy, doxorubicin, and zoledronate with or without strontium-89 in treating patients who have androgen-dependent prostate cancer and bone metastases.
Details: OBJECTIVES: Primary - Compare the effectiveness of hormonal ablative therapy, doxorubicin, and zoledronate with or without strontium chloride Sr 89, in terms of progression-free survival, in patients with androgen-dependent prostate cancer and bone metastases. 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. - Arm I: Patients receive hormonal ablative therapy comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy. Patients also receive doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1. - Arm II: Patients receive hormonal ablative therapy, doxorubicin, and zoledronate as in arm I. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed prostate cancer - Osteoblastic metastases on bone scan or CT scan - Androgen-dependent disease - Previously treated with neoadjuvant or intermittent hormonal ablative therapy* more than 3 years ago AND has reinitiated hormonal ablative therapy within 3 months prior to study entry NOTE: *Therapy was less than 3 years in duration - No symptomatic bulky lymphadenopathy causing scrotal or pedal edema - No significant local invasive disease with bladder invasion - No predominant visceral metastases to the liver or lungs - No small cell carcinoma - No known brain metastases PATIENT CHARACTERISTICS: Age - Not specified Performance status - ECOG 0-3 OR - Karnofsky 40-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - WBC 3,000/mm^3 Hepatic - AST and ALT 2.5 times upper limit of normal - Bilirubin normal Renal - Creatinine < 3.0 mg/dL Cardiovascular - LVEF 45% - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Fertile patients must use effective contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to zoledronate or other study drugs - No other active malignancy except nonmelanoma skin cancer - No other concurrent uncontrolled illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior doxorubicin allowed provided the cumulative dosage was 250 mg/m^2 - No more than 1 prior chemotherapy regimen Endocrine therapy - See Disease Characteristics Radiotherapy - No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery - Not specified Other - Prior zoledronate allowed provided treatment was no more than 3 months in duration - Other prior bisphosphonates allowed - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Shi-MingTu, Study Chair, M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000360625; MDA-NCI-6459,NCI-6459
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081159
Other Recurrent Prostate Cancer Studies:
1. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
2. Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
3. Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
4. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
5. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Clinical Trials
Other Clinical Trials
Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
|
|
|
|
|
|
|
|
