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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00683475 |
The purpose of this study is to determine whether IMC-A12 or IMC-1121B with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Biological: IMC-A12 Drug: Mitoxantrone Drug: Prednisone Biological: IMC-1121B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy |
Estimated Enrollment: | 132 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IMC-1121B + Mitoxantrone + Prednisone: Experimental
IMC-1121B is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-1121B treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met. Mitoxantrone is to be administered as an I.V. infusion, at 12 mg/m2 over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2) or until there is evidence of disease progression. death, or intolerable toxicity. Prednisone (5 mg) is to be self-administered PO BID,each day of the 21-day cycle. |
Drug: Mitoxantrone
Mitoxantrone is to be administered as an I.V. infusion, at 12 mg/m2 over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2) or until there is evidence of disease progression, death, or intolerable toxicity.
Drug: Prednisone
Prednisone (5 mg) is to be self-administered PO BID,each day of the 21-day cycle.
Biological: IMC-1121B
IMC-1121B is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-1121B treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.
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IMC-A12 + Mitoxantrone + Prednisone: Experimental
IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met. Mitoxantrone is to be administered as an I.V. infusion, at 12 mg/m2 over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2) or until there is evidence of disease progression, death, or intolerable toxicity. Prednisone (5 mg) is to be self-administered PO BID,each day of the 21-day cycle. |
Biological: IMC-A12
IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.
Drug: Mitoxantrone
Mitoxantrone is to be administered as an I.V. infusion, at 12 mg/m2 over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2) or until there is evidence of disease progression, death, or intolerable toxicity.
Drug: Prednisone
Prednisone (5 mg) is to be self-administered PO BID,each day of the 21-day cycle.
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Prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer-related death in men in the United States. Chemotherapy, either as a single agent or in combination, may lead to clinical response, pain control, and/or improved quality of life. Docetaxel is now the first-line standard therapy for AIPC. Mitoxantrone was approved in 1996 for use in combination with corticosteroids as initial chemotherapy for pain related to advanced HRPC. Hormonal manipulations and docetaxel-based chemotherapy are often effective in metastatic prostate cancer; however, disease becomes refractory to these interventions in the majority of men. Although mitoxantrone continues to be a significant agent in the treatment of HRPC, there exists a need for more efficacious therapy in docetaxel-refractory- AIPC. Because of the potential contribution of IGF-IR and VEGFR-2 mediated pathways in prostate cancer pathogenesis, it is hypothesized that each of these biological agents in combination with mitoxantrone and prednisone will result in clinically meaningful activity in AIPC. Therefore, ImClone plans to conduct a randomized Phase 2 trial to assess the safety and efficacy of IMC-A12 or IMC-1121B in combination with mitoxantrone and prednisone in patients with AIPC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sarah Capello, MPH | 908-927-8395 | sarah.cappello@imclone.com |
Study Director: | Jonathan Schwartz, MD | ImClone Systems |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP18-0601 |
Study First Received: | May 19, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00683475 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Disease Progression |
Urogenital Neoplasms Mitoxantrone Genital Diseases, Male Prostatic Neoplasms |
Anti-Inflammatory Agents Disease Attributes Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |
Neoplasms Neoplasms by Site Pathologic Processes Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |