Prostate CancerPhase 2NCT00072930
MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer
A Phase 2 study testing MEDI-522 and Docetaxel + Prednisone* + Zoledronic Acid in people with Prostate Cancer, run by MedImmune LLC at 57 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MEDI-522 and Docetaxel + Prednisone* + Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 57 sitesin 7 countries
- Study dates
- Dec 2003to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
57 sites in 7 countries.
57 sites in 7 countries
United States36 sites
New Mexico Oncology Hematology, Consultants Ltd.
Albuquerque, New Mexico, 87109
Clinical Research Services
Bismarck, North Dakota
SUNY Down State Medical Center
Brooklyn, New York, 11203
VA Western New York Healthcare System
Buffalo, New York, 14215-1199
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404
University of Chicago
Chicago, Illinois, 60637-1470
University of Cincinnati, Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
Danville Hematology and Oncology
Danville, Virginia, 24541-4155
North Shore Hematology Oncology Assoc., PC
East Setauket, New York, 11733
Florida Cancer Specialist
Fort Myers, Florida, 33901
South Valley Medical Plaza
Gilroy, California, 95020-3535
Ingalls Hospital
Harvey, Illinois, 60426
Hawaii Medical Consultants
Honolulu, Hawaii, 96817
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216
The Florida Wellcare Alliance, L.C.
Inverness, Florida, 34452
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Western Washington Oncology, Inc., P.S.
Lacey, Washington, 98503
Hemotology/Oncology Associates
Lake Worth, Florida
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89109
The Community Hospital
Munster, Indiana, 46321
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Hematology Oncology Services, LLC
New Orleans, Louisiana, 70115
Columbia Presbyterian Medical Center
New York, New York, 10032-3713
VA Medical Center
Northport, New York, 11768
Raleigh Hematology Oncology Association
Raleigh, North Carolina, 27609
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
Virginia Cancer Institute
Richmond, Virginia, 23230
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
San Bernardino Urological Associates
San Bernardino, California, 92404
Saint Francis Memorial Hospital
San Francisco, California, 94109
Highlands Oncology Group, P.A.
Springdale, Arizona, 72764
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Stanford Advanced Medical Center
Stanford, California, 94305-5826
Santee Hematology/Oncology
Sumter, South Carolina, 29150
Arizona Hematology-Oncology, P.C.
Tucson, Arizona, 85704
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi, 38801
Russia10 sites
Arkhangelsk Regional Oncology Center
Arkhangelsk, 163045
Chelyabinsk Regional Oncology Center
Chelyabinsk, 454087
Kazan City Oncology Center
Kazan', 420111
Blokhin Cancer Research Center
Moscow, 115478
Russian Research Center of Radiology
Moscow, 117387
Semashko Central Clinical Hospital
Moscow, 129128
Medical Rediological Research Centre of Ran
Obninsk, 249036
City Clinical Oncology Dispensary
Saint Petersburg, 198255
Samara Regional Oncology Center
Samara, 443066
Voronezh Regional Oncology Clinical Center
Voronezh, 394000
Belgium4 sites
A.Z. Middelheim
Antwerp, 2020
University Hospital Erasme
Brussels, 1070
Az Groeninge
Kortrijk, 8500
H.-Hartziekenhuis Medische Onocology-Hematologie
Roeselare, 8800
Israel3 sites
Sapir Medical Center - Meir Hospital
Kfar Saba, 44281
Rabin Medical Center
Petah Tikva, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Hungary2 sites
Borsod County Teaching Hospital
Miskolc, H, 3518
Szolnoki Mav Hospital
Szolnok, 5000
About this study
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
The primary objectives of this study are:
- 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
- To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in this patient population.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- MEDI-522, Docetaxel + Prednisone* + Zoledronic Acid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-522Biological
IV at a concentration of 50 mg/mL and 10mL vials
Docetaxel + Prednisone* + Zoledronic AcidBiological
IV 75 mg/m2 IV 3-4 mg 5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55) Receives: Biological: MEDI-522 |
| 2 | Other | Docetaxel + Prednisone + Zoledronic Acid (N=55) Receives: Biological: Docetaxel + Prednisone* + Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Measured: Baseline to disease progression
PSA Response Rate
Measured: Baseline to disease progression
Tumor Response Rate
Measured: 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.
Measured: Baseline to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2003 (estimated)
- Study startDec 2003
- Primary completionApr 2007 (estimated)
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luz Hammershaimb, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072930
- Sponsor's protocol ID
- MI-CP098
- Status last verified
- Jan 2008
- First submitted
- 12 Nov 2003
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00072930
- Acronym / sponsor ID
- MI-CP098
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Apr 2007 (estimated)
- Study completion
- Jun 2007 (actual)
- First posted
- 17 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are:
- 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
- To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in this patient population.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI-522MEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55) |
| 2 | Other | Biological: Docetaxel + Prednisone* + Zoledronic AcidDocetaxel + Prednisone + Zoledronic Acid (N=55) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-522IV at a concentration of 50 mg/mL and 10mL vials | Biological | 1 |
| Docetaxel + Prednisone* + Zoledronic AcidIV 75 mg/m2 IV 3-4 mg 5 mg | Biological | 2 |
Primary outcome
Time to disease progression
Time frame: Baseline to disease progression
PSA Response Rate
Time frame: Baseline to disease progression
Tumor Response Rate
Time frame: Baseline to disease progression
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luz Hammershaimb, MD study director
MedImmune LLC
57 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI-522 and Docetaxel + Prednisone* + Zoledronic Acid in people with Prostate Cancer, run by MedImmune LLC at 57 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Russia, Belgium, Israel, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression (time frame: Baseline to disease progression). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.