Clinical trial NCT00428714: Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy
Official title: Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin.

Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease.

Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen


Eligibility criteria: Inclusion Criteria:

* You are expected to be alive in the 12 weeks.
* You are at least 18 years old.
* You live close enough to the doctor's office to attend all of your required visits.
* You have not been treated with chemotherapy for your prostate cancer (cohort 1).
* Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (\<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of \<=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone \<50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1)
* No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1)
* You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
* You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
* Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2)
* Your organs must be functioning properly.

Exclusion Criteria:

* You are unable to swallow pills.
* You have another illness besides your prostate cancer.
* You have taken another experimental drug within the last 30 days.
* You have a serious heart condition.
* You are receiving another anti-cancer therapy.

Primary outcomes:
measure: Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
timeFrame: Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)
measure: Cohort 2 - Progression-free Survival (PFS)-Overall
timeFrame: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)
Secondary outcomes:
measure: Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30%
timeFrame: baseline to 3 months
measure: Cohort 1 - PSA Velocity
timeFrame: baseline, 2 months and 3 months
measure: Cohort 1 - Progression-free Survival (PFS)-Overall
timeFrame: baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
measure: Cohort 1 - Duration of Response
timeFrame: time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
measure: Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30%
timeFrame: baseline to 3 months
measure: Cohort 2 - PSA Velocity
timeFrame: baseline, 2 months and 3 months
measure: Cohort 2 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
timeFrame: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
measure: Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months
timeFrame: 6 months and 12 months
measure: Cohort 2 - Overall Survival
timeFrame: baseline to date of death from any cause (up to 69.6 weeks)
measure: Cohort 2 - Duration of Response
timeFrame: time of response to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Stanford
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: New Haven
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Connecticut
city: Ann Arbor
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Michigan
city: Las Vegas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nevada
city: Buffalo
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New York
city: New York
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New York
city: Cleveland
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Ohio
city: Lancaster
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Pennsylvania
city: Memphis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tennessee
city: Madison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Dreicer R, Garcia J, Hussain M, Rini B, Vogelzang N, Srinivas S, Somer B, Zhao YD, Kania M, Raghavan D. Oral enzastaurin in prostate cancer: a two-cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy for castrate metastatic disease. Invest New Drugs. 2011 Dec;29(6):1441-8. doi: 10.1007/s10637-010-9428-0. Epub 2010 Apr 6.