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CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
This study has been completed.
First Received: January 5, 2004   Last Updated: November 8, 2006   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00075192
  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 I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Pfizer:

Primary Outcome Measures:
  • Assess safety of combination therapy and effictiveness 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

Estimated Enrollment: 30
Study Start Date: March 2004
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075192

Locations
United States, California
Pfizer Investigational Site
La Masa, California, United States, 91442
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20307
United States, Tennessee
Pfizer Investigational Site
Gallatin, Tennessee, United States, 37066
Pfizer Investigational Site
Hermitage, Tennessee, United States, 37076
Pfizer Investigational Site
Lebanon, Tennessee, United States, 37087
Pfizer Investigational Site
Smyrna, Tennessee, United States, 37167
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site
Nashville, Tennessee, United States, 37207
Pfizer Investigational Site
NASHVILLE, Tennessee, United States, 37211
Pfizer Investigational Site
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Study ID Numbers: A3671004
Study First Received: January 5, 2004
Last Updated: November 8, 2006
ClinicalTrials.gov Identifier: NCT00075192     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Androgen Antagonists
Leuprolide
Bicalutamide
Prostatic Neoplasms
Androgens

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

ClinicalTrials.gov processed this record on July 02, 2009