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Sponsors and Collaborators: |
US Oncology Research ImClone Systems |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00661492 |
To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.
Condition | Intervention | Phase |
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Androgen-Independent Prostate Cancer |
Drug: Erbitux (cetuximab) and Novantrone (mitoxantrone) Drug: Novantrone (mitoxantrone) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-Based Chemotherapy |
Estimated Enrollment: | 130 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator |
Drug: Erbitux (cetuximab) and Novantrone (mitoxantrone)
Arm 1: Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter and Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles
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Arm 2: Active Comparator |
Drug: Novantrone (mitoxantrone)
Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists
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This is a nonblinded, randomized phase II study to determine the activity of Novantrone (mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab) combination in this setting.
Patients will be randomly assigned 2:1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47 patients in Arm 2. A balanced randomization procedure will be performed utilizing a code list that will be developed prior to the study opening. Because the patients will be stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to ensure a balance between the 2 treatment arms.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory criteria for entry:
Exclusion Criteria:
Contact: Stephanie Mull | 832-348-5975 | stephanie.mull@usoncology.com |
Principal Investigator: | Mark T. Fleming, MD | Virginia Oncology Associates/US Oncology |
Responsible Party: | US Oncology ( Angelica McCallister ) |
Study ID Numbers: | 06-118 |
Study First Received: | April 4, 2008 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00661492 |
Health Authority: | United States: Institutional Review Board |
Androgen-independent prostate cancer(AIPC) |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Cetuximab |
Urogenital Neoplasms Mitoxantrone Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Sensory System Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |