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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer  Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 4 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of chemotherapy with or without strontium-89 in treating patients who have prostate cancer that has spread to the bone.
Details: 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 estramustine 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). Patients receive one of two induction chemotherapy regimens. - Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours and vinblastine IV over 30 minutes on day 1, oral ketoconazole three times a day on days 1-7 of weeks 1, 3, and 5, and oral estramustine three times a day on days 1-7 of weeks 2, 4, and 6. - Patients receive oral estramustine twice a day on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-6. Treatment repeats in both regimens every 8 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. 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 one of two 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 3 months. PROJECTED ACCRUAL: Approximately 680 patients (408 randomized) will be accrued for this study within 34 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 estramustine plus docetaxel Endocrine therapy: - See Disease Characteristics - Prior secondary hormonal agents (e.g., aminoglutethimide, diethylstilboestrol, 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 - No prior ketoconazole for patients receiving induction chemotherapy with KAVE
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Shi-MingTu, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Shi-Ming Tu 713-792-2830
Genesis Regional Cancer Center at Genesis Medical Center *Recruiting*
Davenport, Iowa, 52804
United States
Recruiting George Kovach 563-421-1908
Additional Information:
Study ID Numbers: CDR0000068897; MDA-ID-00156,NCI-3410
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024167
Other Stage 4 Prostate Cancer Studies:
1. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer
3. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
4. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
5. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
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