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

January 5, 2004
June 5, 2012
March 2004
Not Provided
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
Not Provided
Complete list of historical versions of study NCT00075192 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
  • Drug: CP-675,206 and leuprolide acetate and bicalutamide
  • Drug: leuprolide acetate and bicalutamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
March 2006
Not Provided

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075192
A3671004
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP