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Phase III Randomized Study of Consolidation Therapy With or Without Strontium Chloride Sr 89 After Induction Chemotherapy in Patients With Androgen-Independent Prostate Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Trial Contact Information Registry Information
Alternate Title
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Active
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Any age
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NCI
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MDA-ID-00156 NCI-3410, 3410, NCT00024167
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Special Category:
CTSU trial 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.
Entry Criteria Disease Characteristics:
- Diagnosis of adenocarcinoma of the prostate
- 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
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 prednisone plus docetaxel
Endocrine therapy: - See Disease Characteristics
- Prior secondary hormonal agents (e.g., aminoglutethimide,
diethylstilbestrol, 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: Other: - No more than 1 prior cytotoxic regimen
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC greater than 3,000/mm3
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic: - Bilirubin no greater than 2 times upper limit of normal
(ULN)
- AST and ALT no greater than 2 times ULN
Renal: 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
Expected Enrollment 480Approximately 480 patients (240 randomized) will be accrued for this study
within 48 months. Outcomes Primary Outcome(s)Overall survival
Outline This is a randomized study. Patients are stratified according to type
of induction chemotherapy (KAVE vs prednisone 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). - Induction therapy: Patients receive 1 of 2 induction therapy regimens.
- Consolidation therapy: 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 1 of 2 consolidation 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 4 weeks until PSA progression and then every 3 months thereafter. Published ResultsTu SM, Kim J, Pagliaro LC, et al.: Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy. J Clin Oncol 23 (31): 7904-10, 2005.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas | | | Shi-Ming Tu, MD, Protocol chair | | Ph: 713-563-7268; 800-392-1611 |
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U.S.A. |
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Georgia |
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Gainesville |
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| | | | | | | | Northeast Georgia Medical Center |
| | Richard LoCicero, MD | |
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Illinois |
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Hines |
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| | | Veterans Affairs Medical Center - Hines |
| | Nirmala Bhoopalam, MD | Ph: | 708-202-8387 ext. 22782 | | |
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Rockford |
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| | Swedish-American Regional Cancer Center |
| | Clinical Trials Office - Swedish-American Regional Cancer Center | |
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Iowa |
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Bettendorf |
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| | | Hematology Oncology Associates of the Quad Cities |
| | Shobha Chitneni, MD, MBBS | |
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Davenport |
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| | Genesis Regional Cancer Center at Genesis Medical Center |
| | George Kovach, MD | |
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Sioux City |
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| | Mercy Medical Center - Sioux City |
| | Donald Wender, MD, PhD | |
| | Siouxland Hematology-Oncology Associates, LLP |
| | Donald Wender, MD, PhD | |
| | St. Luke's Regional Medical Center |
| | Donald Wender, MD, PhD | |
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Mississippi |
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Jackson |
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| | | University of Mississippi Cancer Clinic |
| | Ralph Vance | |
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Missouri |
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Joplin |
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| | | Freeman Cancer Institute at Freeman Health System |
| | Anisa Hassan | |
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Montana |
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Billings |
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| | | Billings Clinic - Downtown |
| | Clinical Trials Office - Billings Clinic - Downtown | |
| Email:
research@billingsclinic.org |
| | CCOP - Montana Cancer Consortium |
| | Benjamin Marchello, MD | Ph: | 406-259-2245 | | 800-361-3239 |
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| | Hematology-Oncology Centers of the Northern Rockies - Billings |
| | Benjamin Marchello, MD | Ph: | 406-238-6290 | | 800-648-6274 |
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| | Northern Rockies Radiation Oncology Center |
| | Benjamin Marchello, MD | Ph: | 406-248-2212 | | 800-358-8818 |
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| | St. Vincent Healthcare Cancer Care Services |
| | Benjamin Marchello, MD | |
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Bozeman |
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| | Bozeman Deaconess Cancer Center |
| | Benjamin Marchello, MD | |
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Butte |
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| | St. James Healthcare Cancer Care |
| | Benjamin Marchello, MD | |
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Great Falls |
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| | Benjamin Marchello, MD | |
| | Big Sky Oncology |
| | Clinical Trail Office - Big Sky Oncology | |
| | Great Falls Clinic - Main Facility |
| | Benjamin Marchello, MD | Ph: | 406-454-2171 | | 800-421-1649 |
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| | Sletten Cancer Institute at Benefis Healthcare |
| | Grant Harrer, MD, FACP, CCTI | |
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Helena |
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| | St. Peter's Hospital |
| | Benjamin Marchello, MD | |
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Kalispell |
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| | Glacier Oncology, PLLC |
| | Benjamin Marchello, MD | |
| | Kalispell Medical Oncology at KRMC |
| | Benjamin Marchello, MD | |
| | Kalispell Regional Medical Center |
| | Benjamin Marchello, MD | |
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Missoula |
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| | Community Medical Center |
| | Benjamin Marchello, MD | |
| | Guardian Oncology and Center for Wellness |
| | Benjamin Marchello, MD | |
| | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center |
| | Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| | Montana Cancer Specialists at Montana Cancer Center |
| | Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center | |
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Nebraska |
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Kearney |
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| | | Good Samaritan Cancer Center at Good Samaritan Hospital |
| | Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital | |
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North Carolina |
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Asheville |
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| | | Mission Hospitals - Memorial Campus |
| | Clinical Trials Office - Mission Hospitals - Memorial Campus | |
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Goldsboro |
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| | Wayne Memorial Hospital, Incorporated |
| | James Atkins, MD | |
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Kinston |
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| | Kinston Medical Specialists |
| | Peter Watson, MD | Ph: | 252-559-2200 ext. 201 | | |
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Ohio |
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Akron |
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| | | Summa Center for Cancer Care at Akron City Hospital |
| | Clinical Trials Office - Akron City Hospital | |
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Salem |
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| | Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford |
| | William Demas, MD | |
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Wooster |
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| | Cancer Treatment Center |
| | Clinical Trials Office - Cancer Treatment Center | |
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South Carolina |
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Florence |
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| | | McLeod Regional Medical Center |
| | Clinical Trials Office - McLeod Regional Medical Center | |
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Tennessee |
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Memphis |
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| | | University of Tennessee Cancer Institute - Memphis |
| | Clinical Trials Office - University of Tennessee Cancer Institute | |
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Texas |
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Dallas |
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| | | Medical City Dallas Hospital |
| | Barry Mirtsching, MD | |
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Houston |
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| | M. D. Anderson Cancer Center at University of Texas |
| | Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas | |
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Wyoming |
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Sheridan |
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| | | Welch Cancer Center at Sheridan Memorial Hospital |
| | Benjamin Marchello, MD | |
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Registry Information | | Official Title | | A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy with or Without Stronium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer | | Trial Start Date | | 2001-10-29 | | Trial Completion Date | | 2004-08-14 (estimated) | | Registered in ClinicalTrials.gov | | NCT00024167 | | Date Submitted to PDQ | | 2001-07-13 | | Information Last Verified | | 2008-07-29 | | NCI Grant/Contract Number | | CA16672, CA45809 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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