Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer
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First Received Date ICMJE | October 7, 2008 | ||||||||||||||||
Last Updated Date | November 23, 2011 | ||||||||||||||||
Start Date ICMJE | October 2008 | ||||||||||||||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
The primary endpoint of the study is to determine the effects of combining androgen deprivation with IMC-A12 on pathologic tumor stage (pathologic complete response). [ Time Frame: At the time of prostatectomy after 3 months of treatment ] [ Designated as safety issue: No ] | ||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00769795 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE | |||||||||||||||||
Original Secondary Outcome Measures ICMJE | |||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer | ||||||||||||||||
Official Title ICMJE | Phase II Study of Neoadjuvant IMC-A12 Combined With Androgen Deprivation Prior to Prostatectomy | ||||||||||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||||||||||
Intervention ICMJE | 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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Study Arm (s) | Experimental: Experimental
Intervention: Drug: IMC-A12 in combination with androgen deprivation therapy |
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Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Enrollment ICMJE | 29 | ||||||||||||||||
Completion Date | November 2011 | ||||||||||||||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Location Countries ICMJE | United States | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT00769795 | ||||||||||||||||
Other Study ID Numbers ICMJE | 6857, NIH P50 CA097186, 6857 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
Responsible Party | Bruce Montgomery, M.D., Associate Professor, Fred Hutch Cancer Research Center (FHCRC) and Seattle Cancer Care Alliance | ||||||||||||||||
Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||||||||||||||
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Investigators ICMJE |
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Information Provided By | Fred Hutchinson Cancer Research Center | ||||||||||||||||
Verification Date | November 2011 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |