MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer
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
1 other identifier
interventional
150
7 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Dec 2003
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2003
CompletedFirst Posted
Study publicly available on registry
November 17, 2003
CompletedStudy Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 15, 2008
January 1, 2008
3.3 years
November 12, 2003
January 11, 2008
Conditions
Outcome Measures
Primary Outcomes (3)
Time to disease progression
Baseline to disease progression
PSA Response Rate
Baseline to disease progression
Tumor Response Rate
Baseline to disease progression
Secondary Outcomes (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.
Baseline to disease progression
Study Arms (2)
1
ACTIVE COMPARATORMEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55)
2
OTHERDocetaxel + Prednisone + Zoledronic Acid (N=55)
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (57)
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216, United States
Highlands Oncology Group, P.A.
Springdale, Arizona, 72764, United States
Arizona Hematology-Oncology, P.C.
Tucson, Arizona, 85704, United States
South Valley Medical Plaza
Gilroy, California, 95020-3535, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
Saint Francis Memorial Hospital
San Francisco, California, 94109, United States
Stanford Advanced Medical Center
Stanford, California, 94305-5826, United States
Florida Cancer Specialist
Fort Myers, Florida, 33901, United States
The Florida Wellcare Alliance, L.C.
Inverness, Florida, 34452, United States
Hemotology/Oncology Associates
Lake Worth, Florida, United States
Hawaii Medical Consultants
Honolulu, Hawaii, 96817, United States
University of Chicago
Chicago, Illinois, 60637-1470, United States
Ingalls Hospital
Harvey, Illinois, 60426, United States
The Community Hospital
Munster, Indiana, 46321, United States
Hematology Oncology Services, LLC
New Orleans, Louisiana, 70115, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi, 38801, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89109, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
New Mexico Oncology Hematology, Consultants Ltd.
Albuquerque, New Mexico, 87109, United States
SUNY Down State Medical Center
Brooklyn, New York, 11203, United States
VA Western New York Healthcare System
Buffalo, New York, 14215-1199, United States
North Shore Hematology Oncology Assoc., PC
East Setauket, New York, 11733, United States
Columbia Presbyterian Medical Center
New York, New York, 10032-3713, United States
VA Medical Center
Northport, New York, 11768, United States
Raleigh Hematology Oncology Association
Raleigh, North Carolina, 27609, United States
Clinical Research Services
Bismarck, North Dakota, United States
University of Cincinnati, Barrett Cancer Center
Cincinnati, Ohio, 45267-0501, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Danville Hematology and Oncology
Danville, Virginia, 24541-4155, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Western Washington Oncology, Inc., P.S.
Lacey, Washington, 98503, United States
A.Z. Middelheim
Antwerp, 2020, Belgium
University Hospital Erasme
Brussels, 1070, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
H.-Hartziekenhuis Medische Onocology-Hematologie
Roeselare, 8800, Belgium
Centre Hospitalier de L'Universite de Montreal
Montreal, H2L 4M1, Canada
Borsod County Teaching Hospital
Miskolc, H, 3518, Hungary
Szolnoki Mav Hospital
Szolnok, 5000, Hungary
Sapir Medical Center - Meir Hospital
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Samodzielny Publiczny Wojewodzki Szpital Zespolony
Słupsk, Poland
Arkhangelsk Regional Oncology Center
Arkhangelsk, 163045, Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, 454087, Russia
Kazan City Oncology Center
Kazan', 420111, Russia
Blokhin Cancer Research Center
Moscow, 115478, Russia
Russian Research Center of Radiology
Moscow, 117387, Russia
Semashko Central Clinical Hospital
Moscow, 129128, Russia
Medical Rediological Research Centre of Ran
Obninsk, 249036, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Samara Regional Oncology Center
Samara, 443066, Russia
Voronezh Regional Oncology Clinical Center
Voronezh, 394000, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luz Hammershaimb, MD
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2003
First Posted
November 17, 2003
Study Start
December 1, 2003
Primary Completion
April 1, 2007
Study Completion
June 1, 2007
Last Updated
January 15, 2008
Record last verified: 2008-01