Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer

NCT00814788 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: UCDCC#215223646Novartis
• Study Type: interventional
• Target: 24
• 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. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response Rate

  The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.

  Up to 2 years

Secondary Outcomes (2)

• Progression-free Survival

  Up to 2 years

• Overall Survival

  Up to 3 years

Study Arms (1)

Bicalutamide + Everolimus

EXPERIMENTAL

Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Bicalutamide; Drug: Everolimus

Interventions

Bicalutamide DRUG

50 mg oral tablet daily

Also known as: Casodex

Bicalutamide + Everolimus

Everolimus DRUG

10 mg oral capsule daily

Also known as: Afinitor, RAD001

Bicalutamide + Everolimus

Eligibility Criteria

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

You may qualify if:

• Participants must be adult males \>18 years.
• Patients must have histologically or cytologically confirmed CaP with a Gleason score available or interpretable.
• Patients must have CaP deemed to be androgen independent.
• Measurable disease is not required.
• Patients must have been surgically or medically castrated. If the method of castration was LHRH agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists. Serum testosterone must be at castrate levels (\< 50 ng/dL) within 3 months prior to registration.
• Participant has not been on any previous therapy with androgen receptor antagonists or mTOR inhibitors. Note: patients who have taken an androgen receptor antagonist for a brief period (no more than 2 months) at the start of LHRH agonist therapy to prevent flare will be considered eligible.
• Men enrolled in this trial must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Patients must have normal organ and marrow function.
• Ability to understand and the willingness to sign a written informed consent document
• ECOG performance status 0-2.
• Patients having any respiratory symptoms such as cough and shortness of breath have undergone pulmonary function testing revealing no worse than mild impairment.

You may not qualify if:

• No documented histological confirmation of CaP.
• Patient has received other hormonal therapy besides first-line androgen deprivation therapy with LHRH agonist, LHRH antagonist, orchiectomy, high-dose steroid, abiraterone, provenge and ketoconazole.
• Patients who have received prior treatment with an mTOR inhibitor.
• 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.
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with RAD001.
• Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
• Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
• Prior treatment with any investigational drug within the preceding 4 weeks.
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
• Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
• Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES.
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
• Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other Stage 0 or I cancers.
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001.
• Patients with an active, bleeding diathesis.

Sponsors & Collaborators

• University of California, Davis: lead
• Novartis: collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Chow H, Ghosh PM, deVere White R, Evans CP, Dall'Era MA, Yap SA, Li Y, Beckett LA, Lara PN Jr, Pan CX. A phase 2 clinical trial of everolimus plus bicalutamide for castration-resistant prostate cancer. Cancer. 2016 Jun 15;122(12):1897-904. doi: 10.1002/cncr.29927. Epub 2016 Mar 28.

  PMID: 27019001 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Everolimus

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)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Analyst
• Organization: University of California Davis

pkaujla@ucdavis.edu

916 734 0294

Study Officials

• Chong-Xian Pan, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 10, 2018
• Results First Posted: June 1, 2017

Record last verified: 2018-01

Locations

US (1)