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Sponsors and Collaborators: |
University of Washington ImClone Systems |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00769795 |
The purpose of this study is to determine whether combination treatment of prostate cancer with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than prior results with hormonal therapy alone.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: IMC-A12 in combination with androgen deprivation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Neoadjuvant IMC-A12 Combined With Androgen Deprivation Prior to Prostatectomy |
Estimated Enrollment: | 28 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Experimental |
Drug: IMC-A12 in combination with androgen deprivation therapy
All participants will begin bicalutamide 50 mg p.o. daily, one week prior to goserelin administration. On study day 1 the patients will be administered a single dose of goserelin 10.8 mg s.q. and continue on bicalutamide 50 mg daily for the duration of the trial. Total treatment length is 13 weeks. IMC-A12 will be administered every 2 weeks for a total of 6 doses at 10 mg/kg per dose. The last dose of IMC-A12 will be at least 2 weeks prior to prostatectomy.
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Androgen deprivation has long been the principal means of controlling advanced prostate cancer, but it does not cure the disease and all patients ultimately progress if tumor is not eliminated with definitive local therapy. Neoadjuvant androgen deprivation prior to radical prostatectomy can downstage localized disease and reduce the likelihood of residual disease at the margins, but does not improve failure free survival. It has been demonstrated that despite androgen deprivation with luteinizing hormone releasing hormone (LHRH) agonists or orchiectomy, prostate tissue and prostate cancer maintain levels of androgens which are more than adequate to continue to stimulate the androgen receptor and downstream signaling. These levels of androgen may continue to allow both survival of tumor cells and induction of resistance by overexpression of receptor.
The anti-insulin-like growth factor type I receptor (IGF-IR) antibody IMC-A12 blocks translocation of the androgen receptor to the nucleus, dramatically augmenting efficacy of androgen deprivation in human prostate xenograft models. The combination of androgen deprivation with IMC-A12 is anticipated to more effectively treat cancer within the prostate, optimizing local control, while potentially eliminating micrometastatic disease. We propose to test this hypothesis in this phase II study, administering neoadjuvant androgen deprivation therapy IMC-A12 prior to radical prostatectomy for patients with clinically localized, high risk prostate cancer for 3 months.
Patients with clinically localized, and surgically resectable (cT1-T3) prostate cancer, at high risk for relapse who are candidates for radical prostatectomy will be treated with LHRH agonist and androgen receptor antagonist combined with IMC-A12, 10 mg/kg given intravenously every 14 days for 12 weeks. Patients will undergo biopsy of the prostate prior to treatment and radical prostatectomy 12 weeks after initiation of treatment.
The primary endpoint of the study is to evaluate the ability of LHRH agonist with IMC-A12 to induce a complete pathologic remission
Samples from the current study will be compared to control, untreated prostatectomy specimens from the Northwest Prostate SPORE Tissue Core and a concurrent set of specimens from patients treated with 12 weeks of combined androgen deprivation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sara Teller, B.A. | 206-598-0854 | saratell@u.washington.edu |
Contact: Seattle Cancer Care Alliance New Patient Intake | 206-288-6542 |
United States, Washington | |
University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Sara Teller, B.A. 206-598-0854 saratell@u.washington.edu | |
Principal Investigator: Bruce Montgomery, M.D. | |
Sub-Investigator: James Dean, M.D., Ph.D. | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Sara Teller, B.A. 206-598-0854 saratell@u.washington.edu | |
Principal Investigator: Bruce Montgomery, M.D. | |
Principal Investigator: James P. Dean, M.D., Ph.D. |
Principal Investigator: | Bruce Montgomery, M.D. | University of Washington and Seattle Cancer Care Alliance |
Principal Investigator: | James P Dean, M.D., Ph.D. | University of Washington and Seattle Cancer Care Alliance |
Principal Investigator: | Stephen Plymate, M.D. | University of Washington |
Responsible Party: | University of Washington and Seattle Cancer Care Alliance ( Bruce Montgomery, M.D., Associate Professor ) |
Study ID Numbers: | 33397, NIH P50 CA097186 |
Study First Received: | October 7, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00769795 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer prostatic neoplasm androgen deprivation therapy |
insulin-like growth factor receptor I neoadjuvant prostatectomy |
Antibodies Prostatic Diseases Genital Neoplasms, Male Goserelin Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Insulin Immunoglobulins |
Neoplasms Neoplasms by Site |