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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075192
• Other study ID #: A3671004
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 5, 2004
• Last updated: June 5, 2012
• Start date: March 2004
• Est. completion date: March 2006

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• CP-675,206 and leuprolide acetate and bicalutamide

• leuprolide acetate and bicalutamide

Locations

Country	Name	City	State
United States	Research Site	Gallatin	Tennessee
United States	Research Site	Hermitage	Tennessee
United States	Research Site	La Masa	California
United States	Research Site	Lebanon	Tennessee
United States	Research Site	Murfreesboro	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Smyrna	Tennessee
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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