Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

NCT01050842 | Completed Early Phase 1 DMC

• 3 other identifiers: MC0851NCI-2009-0170007-008912
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer. PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Progression-free survival rate

  6 months

• Adverse events of combined treatment with bicalutamide and raloxifene as measured by CTCAE version 3.0

• Quality of life as assessed by Linear Analogue Self Assessment (LASA6) and the Hormonal Domain scale of the Expanded Prostate Cancer Index Composite (EPIC-H) survey

• Survival time

• Measurable or evaluable disease as assessed by RECIST

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral bicalutamide and oral raloxifene on days 1-28.

Drug: bicalutamide; Drug: raloxifene; Procedure: quality-of-life assessment

Interventions

bicalutamide DRUG

Given orally

Also known as: Casodex, CDX, Cosudex, ICI 176,334

Arm I

raloxifene DRUG

Given orally

Also known as: Evista, Keoxifene, LY 139481, RALOX

Arm I

quality-of-life assessment PROCEDURE

Ancillary study

Also known as: quality of life assessment

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of prostate adenocarcinoma
• Objective disease progression or rising PSA despite androgen deprivation therapy
• Progression of measurable disease assessed within 28 days prior to registration; progression of non-measurable disease assessed within 28 days prior to registration; patients with rising PSA must demonstrate a rising trend with two successive elevations at a minimum interval of two weeks
• Patients must have been surgically or medically castrated; if the method of castration is LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists; castration using LHRH agonist should not be interrupted and patients who have stopped treatment should be willing to restart
• If the patient has been treated with non-steroidal antiandrogens (bicalutamide, flutamide, nilutamide, or ketoconazole) then they must have stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for bicalutamide, flutamide, or nilutamide and the patients must have demonstrated progression
• Any patient with documented antiandrogen withdrawal syndrome with bicalutamide would not be eligible
• A minimum PSA of 5 ng/ml or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measureable disease
• ECOG Performance Status (PS) 0, 1, or 2
• ANC \>= 1500
• PLT \>= 100,000
• HgB \>= 9.0 g/dL
• Total bilirubin =\< 1.5 x UNL
• SGOT (AST) =\< 3 x UNL
• SGPT (ALT) =\< 3 x UNL
• Alkaline Phosphatase =\< 3 x UNL

You may not qualify if:

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects
• Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects
• The use of bisphosphonates is allowed provided that the patient has been receiving that medication for \>= 4 weeks with evidence of progressive disease
• Prior systemic therapy to treat prostate cancer including cytotoxic chemotherapy, biologic therapy, vaccine therapy, and experimental therapy is allowed, and at least 28 days must have elapsed since completion of therapy and the patient must have recovered from all side effects
• No concurrent use of estrogen, estrogen-like agents, or other hormonal therapy is allowed; prior use of these agents will need to be discontinued \>= 4 weeks prior to registration
• Active other malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, must not be receiving other specific treatment (other than hormonal therapy) for cancer
• History of congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Experienced documented anti-androgen withdrawal syndrome on bicalutamide
• History of venous thromboembolic disease or significant risk for venous thromboembolic disease
• History of symptomatic coronary artery disease
• History of stroke or significant risk for stroke

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic In Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Erik P. Castle, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: October 4, 2012
• Last Updated: March 23, 2017

Record last verified: 2016-03

Locations

US (1)