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MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00072930
Recruitment Status : Completed
First Posted : November 17, 2003
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
MedImmune LLC

Brief Summary:

The primary objectives of this study are:

  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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: MEDI-522 Biological: Docetaxel + Prednisone* + Zoledronic Acid Phase 2

Detailed Description:
This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in patients with metastatic AIPC.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination With Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer
Study Start Date : December 2003
Estimated Primary Completion Date : April 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
MEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55)
Biological: MEDI-522
IV at a concentration of 50 mg/mL and 10mL vials

2
Docetaxel + Prednisone + Zoledronic Acid (N=55)
Biological: Docetaxel + Prednisone* + Zoledronic Acid
IV 75 mg/m2 IV 3-4 mg 5 mg




Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: Baseline to disease progression ]
  2. PSA Response Rate [ Time Frame: Baseline to disease progression ]
  3. Tumor Response Rate [ Time Frame: Baseline to disease progression ]

Secondary Outcome Measures :
  1. Anti-bone resorption assessed as the incidence of skeletal related events (SREs). (SREs) are defined as radiotherapy, surgery, pathologic bone fracture, spinal cord fracture. Overall survival will also be measured. [ Time Frame: Baseline to disease progression ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men at least 18 years of age at the time of randomization.
  • 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:
  • There is evidence of disease progression (defined in Inclusion Criteria #2) following withdrawal of antiandrogens; and b. At least 4 weeks for flutamide or 6 weeks for bicalutamide have passed since last treatment.
  • 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 chemotherapy for metastatic prostate cancer (prior adjuvant chemotherapy is allowed provided it is non-taxane based and at least 6 months have passed since last treatment).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072930


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Locations
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United States, Alabama
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
United States, Arizona
Highlands Oncology Group, P.A.
Springdale, Arizona, United States, 72764
Arizona Hematology-Oncology, P.C.
Tucson, Arizona, United States, 85704
United States, California
South Valley Medical Plaza
Gilroy, California, United States, 95020-3535
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
Saint Francis Memorial Hospital
San Francisco, California, United States, 94109
Stanford Advanced Medical Center
Stanford, California, United States, 94305-5826
United States, Florida
Florida Cancer Specialist
Fort Myers, Florida, United States, 33901
The Florida Wellcare Alliance, L.C.
Inverness, Florida, United States, 34452
Hemotology/Oncology Associates
Lake Worth, Florida, United States
United States, Hawaii
Hawaii Medical Consultants
Honolulu, Hawaii, United States, 96817
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
Ingalls Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
The Community Hospital
Munster, Indiana, United States, 46321
United States, Louisiana
Hematology Oncology Services, LLC
New Orleans, Louisiana, United States, 70115
United States, Minnesota
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, Mississippi
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1010
United States, Nevada
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89109
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New Mexico
New Mexico Oncology Hematology, Consultants Ltd.
Albuquerque, New Mexico, United States, 87109
United States, New York
SUNY Down State Medical Center
Brooklyn, New York, United States, 11203
VA Western New York Healthcare System
Buffalo, New York, United States, 14215-1199
North Shore Hematology Oncology Assoc., PC
East Setauket, New York, United States, 11733
Columbia Presbyterian Medical Center
New York, New York, United States, 10032-3713
VA Medical Center
Northport, New York, United States, 11768
United States, North Carolina
Raleigh Hematology Oncology Association
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Clinical Research Services
Bismark, North Dakota, United States
United States, Ohio
University of Cincinnati, Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501
United States, South Carolina
Santee Hematology/Oncology
Sumter, South Carolina, United States, 29150
United States, Tennessee
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37404
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Virginia
Danville Hematology and Oncology
Danville, Virginia, United States, 24541-4155
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Western Washington Oncology, Inc., P.S.
Lacey, Washington, United States, 98503
Belgium
A.Z. Middelheim
Antwerpen, Belgium, 2020
University Hospital Erasme
Bruxelles, Belgium, 1070
Az Groeninge
Kortrijk, Belgium, 8500
H.-Hartziekenhuis Medische Onocology-Hematologie
Roeselare, Belgium, 8800
Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Canada, H2L 4M1
Hungary
Borsod County Teaching Hospital
Miskolc, H, Hungary, 3518
Szolnoki Mav Hospital
Szolnok, Hungary, 5000
Israel
Sapir Medical Center - Meir Hospital
Kfar Saba, Israel, 44281
Rabin Medical Center
Petach Tikva, Israel, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Poland
Samodzielny Publiczny Wojewodzki Szpital Zespolony
Slupsk, Poland
Russian Federation
Arkhangelsk Regional Oncology Center
Arkhangelsk, Russian Federation, 163045
Chelyabinsk Regional Oncology Center
Chelyabinsk, Russian Federation, 454087
Kazan City Oncology Center
Kazan, Russian Federation, 420111
Blokhin Cancer Research Center
Moscow, Russian Federation, 115478
Russian Research Center of Radiology
Moscow, Russian Federation, 117387
Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
Medical Rediological Research Centre of Ran
Obninsk, Russian Federation, 249036
City Clinical Oncology Dispensary
Saint Petersburg, Russian Federation, 198255
Samara Regional Oncology Center
Samara, Russian Federation, 443066
Voronezh Regional Oncology Clinical Center
Voronezh, Russian Federation, 394000
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: Luz Hammershaimb, MD MedImmune LLC

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Responsible Party: Luz Hammershaimb, M.D., V.P., Clinical Dev., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00072930     History of Changes
Other Study ID Numbers: MI-CP098
First Posted: November 17, 2003    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic Acid
Prednisone
Docetaxel
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents