CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00075192

First received: January 5, 2004

Last updated: June 5, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 5, 2004
Last Updated Date	June 5, 2012
Start Date ^ICMJE	March 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: May 9, 2011)	Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00075192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 27, 2005)	assess Pk during treatment monitor for human anti-human antibodies at the end of the study explore genetic influences on safety and/or immune response
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
Official Title ^ICMJE	A Phase 1, Open Label, Non-Randomized, Dose Escalation Study to Evaluate the Safety of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2, Open Label, Randomized Study to Evaluate the Efficacy of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer
Brief Summary	This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostatic Neoplasms
Intervention ^ICMJE	Drug: CP-675,206 and leuprolide acetate and bicalutamide Drug: leuprolide acetate and bicalutamide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8
Completion Date	March 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate, previously untreated Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA >10 and d20 or Gleason score 7 or cT2b No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis Age > 18 years ECOG performance status 0-1 Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology Exclusion Criteria: Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer History of, or significant risk for, chronic inflammatory or autoimmune disease Potential requirement for systemic corticosteroids before surgery based on prior history History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy Coexisting malignancies except basal or squamous cell carcinoma of the skin
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	NCT00075192
Other Study ID Numbers ^ICMJE	A3671004
Has Data Monitoring Committee	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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