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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00075192
• Collaborator: (none)
• Enrollment: 8
• Locations: 11
• Duration (Months): 24
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: CP-675,206 and leuprolide acetate and bicalutamide; Drug: leuprolide acetate and bicalutamide	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2004
• Actual Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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 []

Secondary Outcome Measures

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	La Masa	California	United States	91442
2	Research Site	Washington	District of Columbia	United States	20307
3	Research Site	Gallatin	Tennessee	United States	37066
4	Research Site	Hermitage	Tennessee	United States	37076
5	Research Site	Lebanon	Tennessee	United States	37087
6	Research Site	Murfreesboro	Tennessee	United States	37130
7	Research Site	Nashville	Tennessee	United States	37203
8	Research Site	Nashville	Tennessee	United States	37205
9	Research Site	Nashville	Tennessee	United States	37207
10	Research Site	Nashville	Tennessee	United States	37211
11	Research Site	Smyrna	Tennessee	United States	37167

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00075192
• Other Study ID Numbers: A3671004
• First Posted: Jan 7, 2004
• Last Update Posted: Jun 6, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Prostatic Neoplasms; Leuprolide; Bicalutamide; Tremelimumab

Study Results

No Results Posted as of Jun 6, 2012