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
  Purpose

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 Intervention Phase
Prostatic Neoplasms
Drug: CP-675,206 and leuprolide acetate and bicalutamide
Drug: leuprolide acetate and bicalutamide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 8
Study Start Date: March 2004
Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075192

Locations
United States, California
Research Site
La Masa, California, United States, 91442
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20307
United States, Tennessee
Research Site
Gallatin, Tennessee, United States, 37066
Research Site
Hermitage, Tennessee, United States, 37076
Research Site
Lebanon, Tennessee, United States, 37087
Research Site
Murfreesboro, Tennessee, United States, 37130
Research Site
Nashville, Tennessee, United States, 37203
Research Site
Nashville, Tennessee, United States, 37205
Research Site
Nashville, Tennessee, United States, 37207
Research Site
Nashville, Tennessee, United States, 37211
Research Site
Smyrna, Tennessee, United States, 37167
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00075192     History of Changes
Other Study ID Numbers: A3671004
Study First Received: January 5, 2004
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Leuprolide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014