MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer
NCT ID: NCT00072930
Last Updated: 2008-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2003-12-31
2007-06-30
Brief Summary
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1. To explore the antitumor activity of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in patients with metastatic Androgen-Independent Prostate Cancer (AIPC); and
2. To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in this patient population.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
MEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55)
MEDI-522
IV at a concentration of 50 mg/mL and 10mL vials
2
Docetaxel + Prednisone + Zoledronic Acid (N=55)
Docetaxel + Prednisone* + Zoledronic Acid
IV 75 mg/m2 IV 3-4 mg 5 mg
Interventions
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MEDI-522
IV at a concentration of 50 mg/mL and 10mL vials
Docetaxel + Prednisone* + Zoledronic Acid
IV 75 mg/m2 IV 3-4 mg 5 mg
Eligibility Criteria
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Inclusion Criteria
* Metastatic, histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after start of androgen deprivation therapy, which includes prior orchiectomy or medical castration using leuteinizing hormone-releasing hormone (LHRH) antagonists such as leuprolide or goserelin (patients must remain on LHRH analogue therapy for the duration of the study if not surgically castrated). Progressive disease should be documented by:
a. PSA progression (defined as two consecutive increases in PSA over a previous reference value, with the first increase in PSA occurring at a minimum of 1 week after the reference value \[obtained within 2 months prior to study randomization\] and confirmed by a subsequent increase in PSA whose value must be ³ 5 ng/mL prior to study randomization);41 and one of the following: i. Bone metastases (defined as ³3 foci on bone scan and confirmed radiologically within 1 month prior to study randomization); or ii. Measurable non-bony metastatic disease (documented by radiographic studies performed within 1 month prior to study randomization).
* Serum testosterone levels \<50 ng/dL documented in non-surgically castrated patients within 21 days prior to randomization.
* Prior treatment with nonsteroidal antiandrogens (e.g., flutamide or bicalutamide) is allowed provided:
* Prior treatment with ketoconazole and/or steroids is allowed provided at least 4 weeks have passed since last treatment. There are no restrictions for use of prednisone (5 mg twice daily) or another functionally equivalent oral corticosteroid for treatment of pain.
* In the rare instance a patient is potent, he must agree to practice an effective method of contraception including condom or abstinence, unless his sexual partner is sterile, from the time of first administration of MEDI-522 or docetaxel through 30 days after the last dose of either docetaxel or MEDI-522, whichever is the last drug discontinued.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 documented within 21 days prior to randomization.
* Life expectancy, in the opinion of the investigator, of at least 6 months.
* White blood cell (WBC) count ≥ 3,000/mm3; absolute neutrophil count (ANC) ≥ 1,500/mm3; platelet count ≥ 100,000/mm3; and hemoglobin ³ 9 g/dL documented within 21 days prior to randomization.
* Bilirubin ≤ ULN; aspartate transaminase (AST)/alanine transaminase (ALT) £1.5 times ULN or if AST/ALT is \>1.5 times ULN, then alkaline phosphatase must be £2.5 times ULN; serum creatinine ≤ 1.5 mg/dL; INR within normal range, unless a patient is receiving anticoagulation therapy; and corrected serum calcium between 8.0-11.5 mg/dL documented within 21 days prior to randomization.
* Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery and all surgical wounds have healed prior to study randomization.
* Prior radiotherapy including therapeutic isotopes is allowed provided measurable or evaluable disease that is clearly progressing is present and all acute radiation-related toxicities have resolved prior to study randomization.
* Prior treatment with unconventional therapy for malignancy (e.g., vitamins, St. John's Wort, PC-SPES, saw palmetto, or other herbal remedies) is allowed provided at least 4 weeks have passed since last treatment prior to randomization.
* Written informed consent and HIPAA authorization (USA sites only) obtained from the patient prior to receipt of any study medication or beginning study procedures.
Exclusion Criteria
* Prior treatment with other investigational agents within 4 weeks prior to randomization.
* Planned concurrent treatment with unconventional therapy for malignancy (e.g., vitamins, St. John's Wort, PC-SPES, saw palmetto, or other herbal other herbal remedies) based on medical history. Currently requiring anticoagulation (excluding use of heparin flush solutions for maintenance of catheter lines) for any thromboembolic disease based on medical history and physical examination.
* Current or planned participation (from the time of randomization through 30 days after the last dose of either docetaxel or MEDI-522, whichever is the last drug discontinued) in a research protocol in which an investigational agent or therapy may be administered.
* Any evidence of or history elicited by the investigator of prior treatment with MEDI-522 or MEDI-523.
* Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to randomization.
* Clinically evident central nervous system (CNS) metastasis.
* History of prior malignancies within the past 5 years other than adequately treated basal cell or squamous cell skin cancer or Stage I or II cancer currently in complete remission;
* Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., warfarin or heparin).
* Any evidence of or history elicited by the investigator of myocardial infarction or angina within 6 months prior to randomization.
* Any evidence of or history elicited by the investigator of hematemesis, melena, hematochezia, or uncontrolled gross hematuria within 4 weeks prior to randomization.
* Any evidence of or history elicited by the investigator of bleeding diatheses.
* Major elective surgery planned from the time of randomization through 30 days after the last dose of either docetaxel or MEDI-522, whichever is the last drug discontinued.
* Any evidence of or history elicited by the investigator of hypersensitivity to a previously administered monoclonal antibody.
* Any evidence of or history elicited by the investigator of hypersensitivity to drugs formulated with polysorbate 80, prednisone (or other functionally equivalent oral corticosteroid), or zoledronic acid.
* Known human immunodeficiency virus (HIV) or known active viral hepatic infections based on medical history and physical examination.
* Any evidence of or history elicited by the investigator of uncontrolled or refractory hypertension or uncontrolled diabetes despite medication within 6 months prior to randomization.
* Any evidence of or history elicited by the investigator of an active infection requiring parenteral anti-infective therapy.
* A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
18 Years
MALE
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune Inc.
Principal Investigators
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Luz Hammershaimb, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Clinical Research Consultants, Inc.
Hoover, Alabama, United States
Highlands Oncology Group, P.A.
Springdale, Arizona, United States
Arizona Hematology-Oncology, P.C.
Tucson, Arizona, United States
South Valley Medical Plaza
Gilroy, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
Saint Francis Memorial Hospital
San Francisco, California, United States
Stanford Advanced Medical Center
Stanford, California, United States
Florida Cancer Specialist
Fort Myers, Florida, United States
The Florida Wellcare Alliance, L.C.
Inverness, Florida, United States
Hemotology/Oncology Associates
Lake Worth, Florida, United States
Hawaii Medical Consultants
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Ingalls Hospital
Harvey, Illinois, United States
The Community Hospital
Munster, Indiana, United States
Hematology Oncology Services, LLC
New Orleans, Louisiana, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
New Mexico Oncology Hematology, Consultants Ltd.
Albuquerque, New Mexico, United States
SUNY Down State Medical Center
Brooklyn, New York, United States
VA Western New York Healthcare System
Buffalo, New York, United States
North Shore Hematology Oncology Assoc., PC
East Setauket, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
VA Medical Center
Northport, New York, United States
Raleigh Hematology Oncology Association
Raleigh, North Carolina, United States
Clinical Research Services
Bismarck, North Dakota, United States
University of Cincinnati, Barrett Cancer Center
Cincinnati, Ohio, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Danville Hematology and Oncology
Danville, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Western Washington Oncology, Inc., P.S.
Lacey, Washington, United States
A.Z. Middelheim
Antwerp, , Belgium
University Hospital Erasme
Brussels, , Belgium
Az Groeninge
Kortrijk, , Belgium
H.-Hartziekenhuis Medische Onocology-Hematologie
Roeselare, , Belgium
Centre Hospitalier de L'Universite de Montreal
Montreal, , Canada
Borsod County Teaching Hospital
Miskolc, H, , Hungary
Szolnoki Mav Hospital
Szolnok, , Hungary
Sapir Medical Center - Meir Hospital
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Samodzielny Publiczny Wojewodzki Szpital Zespolony
Słupsk, , Poland
Arkhangelsk Regional Oncology Center
Arkhangelsk, , Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, , Russia
Kazan City Oncology Center
Kazan', , Russia
Blokhin Cancer Research Center
Moscow, , Russia
Russian Research Center of Radiology
Moscow, , Russia
Semashko Central Clinical Hospital
Moscow, , Russia
Medical Rediological Research Centre of Ran
Obninsk, , Russia
City Clinical Oncology Dispensary
Saint Petersburg, , Russia
Samara Regional Oncology Center
Samara, , Russia
Voronezh Regional Oncology Clinical Center
Voronezh, , Russia
Countries
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Other Identifiers
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MI-CP098
Identifier Type: -
Identifier Source: org_study_id
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