A Safety and Feasibility Study of Mitotane in Prostate Cancer

NCT02057237 | Completed Phase 1 Results DMC

• 1 other identifier: MITO222
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The primary objective of this study is to assess the feasibility of treating patients with metastatic castration resistant prostate cancer with mitotane. Secondary objectives are to assess safety and tolerability as well as response rate of therapy
2. 2.To assess the toxicity of Mitotane in men with HRPC
3. 3.To assess the relationship between baseline serum adrenal androgens and their response to Mitotane

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events

  maintain 50% of the patients on Mitotane at the 12 week mark

Secondary Outcomes (1)

• Prostate Specific Antigen (PSA) Response Rate

  PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.

Study Arms (1)

single arm

EXPERIMENTAL

Mitotane will be administered on an outpatient or inpatient basis.

Drug: Mitotane

Interventions

Mitotane DRUG

Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily

Also known as: Lysodren

single arm

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven prostate cancer OR a clinical picture consistent with metastatic prostate cancer with high levels of serum PSA (\>20ng/ml)
• Progressed on docetaxel chemotherapy after a minimum of 3 cycles and/or stopped treatment because of toxicity. Patients may have had previous mitoxantrone, either before or after docetaxel treatment
• Response to a minimum of a 50% fall in PSA maintained for 4 weeks and then progressed through abiraterone treatment
• At least 2 consecutive rising PSAs measured at least 1 week apart . Patients must have ceased abiraterone at least 1 week prior.
• Serum PSA \> 10 ng/ml
• ECOG performance status \</= 1 (Karnofsky \>/=60%)
• Normal organ and marrow function as defined:
• Absolute neutrophils count ≥ 1,500/uL
• platelets ≥100,000/uL
• total bilirubin ≤1.5 X institutional ULN
• AST(SGOT)/ALT(SGPT) ≤ 2 X institutional ULN
• creatinine ≤ 1.5 X institutional ULN
• Men must agree to use adequate contraception prior to study entry
• Life expectancy \> 3 months
• CRPC documented by PSA increase despite having: a) orchidectomy OR b) continuous LHRH agonist treatment. This should be documented by a baseline serum testosterone suppression (\<1.75 nmol/L)

You may not qualify if:

• Prior anticancer treatment with Mitotane
• May not be receiving any other investigational or anticancer agents while on study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g. Sjogrens etc.) or gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis) or psychiatric illness/social situations that would limit compliance with study requirements
• Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
• Radiotherapy within the past 4 weeks
• Pre-existing pituitary or adrenal dysfunction
• Patients on spironolactone as this may interfere with the action of mitotane
• Patients on warfarin as mitotane may unpredictably interfere with INR measurements

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mitotane

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)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Anthony Joshua
• Organization: Princess Margaret Cancer Centre

anthony.joshua@uhn.ca

416-946-4501

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 7, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2015-11

Locations

CA (1)