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Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Stage IV Prostate Cancer

Thank you

Trial Information

Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer


OBJECTIVES:

I. To describe the 6-month progression-free survival rate, progression-free survival, and
overall survival of patients receiving bicalutamide and raloxifene.

II. To describe the adverse event profile of combined treatment with bicalutamide and
raloxifene (adverse events graded using the NCI CTCAE version 3.0).

III. To describe the quality of life of patients receiving bicalutamide and raloxifene.

OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment
repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 3
years.


Inclusion Criteria:



- 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

- Creatinine =< 1.5 x UNL

- Ability to complete questionnaire(s) independently or with assistance

- Provide informed written consent

- Willingness to return to Mayo Clinic enrolling institution for follow-up

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Erik P. Castle, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

MC0851

NCT ID:

NCT01050842

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404