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

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

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Leuprolide acetate Leuprolide Bicalutamide

U.S. FDA Resources

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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Leuprolide

Bicalutamide

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Pharmacologic Actions

Neoplasms

Androgen Antagonists

Neoplasms by Site

Fertility Agents, Female

Therapeutic Uses

Fertility Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00075192