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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00537381 |
The purpose of this study is to assess the effects (good and bad) of CNTO 95 when given in combination with docetaxel and prednisone to patients with metastatic hormone refractory prostate cancer (HRPC).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Placebo, docetaxel, prednisone Biological: CNTO 95, docetaxel, prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | November 2009 |
Arms | Assigned Interventions |
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001: Placebo Comparator |
Drug: Placebo, docetaxel, prednisone
Placebo infusions once a week for first 7 weeks then every 3 weeks until week 76; docetaxel - infusion of 75mg/kg every 3 wks through wk 76; prednisone - 5mg oral two times a day
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002: Experimental |
Biological: CNTO 95, docetaxel, prednisone
Infusion of 10 mg/kg once a wk for first 7 wks then every 3 wks through wk 76; docetaxel - infusion of 75mg/kg every 3 wks through wk 76; prednisone - 5mg oral two times a day
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CNTO 95 is an antibody. Antibodies are substances in the body that fight infection. CNTO 95 is thought to work by blocking substances on cells called integrins that are involved in formation of new blood vessels (angiogenesis).
More specifically, cancer drugs like CNTO 95, work by preventing the formation of blood vessels that feed tumors.
These types of cancer drugs are called anti-angiogenic drugs. When new blood vessels are stopped from being made, cancer tumors cannot get the food and oxygen they need to grow. As a result anti-angiogenic drugs may stop cancer tumors from growing and spreading. In this study the combination of CNTO 95 with docetaxel and prednisone will be tested to see if it is safe and to see what effects it has on cancer. Docetaxel and prednisone are approved chemotherapy (cancer drug) for Hormone Refractory Prostate Cancer (HRPC). If eligible to take part in this study, the patient will be randomly placed into one of two study groups. The study is "blinded". This means that neither the patient nor the study doctor will know which group the patient is placed. The patient will have an equal chance of being put in either group. There will be 2 study groups. In Group 1, patients will receive docetaxel (75 mg/m2) and prednisone plus placebo. In Group 2, patients will receive docetaxel (75 mg/m2) and prednisone plus CNTO 95 (10 mg/kg). Placebo is an inactive or dummy treatment that looks the same as CNTO 95, but does not contain any active medication. Placebo (group 1) / CNTO 95 (group 2) and docetaxel are given through a small tube that goes directly into your vein; this is called an intravenous (IV) infusion. The infusion of docetaxel (75 mg/ m2) will be given every 3 weeks. Placebo/CNTO 95 will be given weekly for the first 7 weeks and every three weeks thereafter. If the patient's cancer gets worse, both the patient and the study doctor will be able to find out what group the patient was placed in. If the patient was placed in Group 1, and received placebo, the patient will be given the option to continue in the study and receive CNTO 95 (10mg/kg) rather than placebo. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of assessment of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events. Patient participation in the study will last up to 76 weeks.
An infusion (into the vein) of placebo or CNTO 95 will be given once a week for the first 7 weeks and every three weeks thereafter. An infusion (into the vein) of docetaxel (75 mg/m2 will be given every 3 weeks and prednisone tablets twice a day for up to one year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Centocor Inc. ( Director Clinical Research ) |
Study ID Numbers: | CR013249, C1034T08 |
Study First Received: | September 27, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00537381 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Docetaxel CNTO 95 Prednisone prostate cancer infusion |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Hormones Glucocorticoids Docetaxel Antibodies, Monoclonal Antibodies Prostatic Neoplasms Immunoglobulins |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |