Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 4:53 AM
Study NCT ID:
NCT00685633
Status:
WITHDRAWN
Last Update Posted:
2013-08-20
First Post:
2008-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bicalutamide With or Without Enzastaurin in Treating Patients With Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Phase II, Randomized Study of Patients With Rising PSA at High-Risk of Progression After Primary Therapy to Assess the Clinical and Molecular Efficacy of the Enzastaurin - Bicalutamide Combination to Suppress the Androgen Receptor Without Testosterone Ablation
Status:
WITHDRAWN
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving bicalutamide together with enzastaurin is more effective than bicalutamide alone in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying bicalutamide to see how well it works compared with giving bicalutamide together with enzastaurin in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying bicalutamide to see how well it works compared with giving bicalutamide together with enzastaurin in treating patients with prostate cancer.
Detailed Description:
OBJECTIVES:
Primary
* To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks.
Secondary
* To assess the proportion of patients with PSA decline \> 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm.
* To assess the distribution of best PSA response in each study arm.
* To assess the time to PSA progression and the time to PSA nadir in each arm of the study.
* To assess the duration of PSA response in each arm of the study.
* To characterize the PSA slope before, during, and after treatment.
* To evaluate the safety and tolerability of enzastaurin hydrochloride in this patient population.
* To determine whether Gleason score or prior hormonal therapy has any effect on PSA response to treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 6 vs 7 vs 8-10) and prior hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm A:
* Weeks 1-12: Patients are observed without treatment. Patients with a prostate-specific antigen (PSA) rise of \> 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician.
* Weeks 13-44: Patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks.
* Arm B:
* Weeks 1-12: Patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of \> 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician.
* Weeks 13-44: Patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks.
After completion of study treatment, patients are followed every 3 months for 5 years, and then every 6 months for up to 10 years.
Primary
* To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks.
Secondary
* To assess the proportion of patients with PSA decline \> 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm.
* To assess the distribution of best PSA response in each study arm.
* To assess the time to PSA progression and the time to PSA nadir in each arm of the study.
* To assess the duration of PSA response in each arm of the study.
* To characterize the PSA slope before, during, and after treatment.
* To evaluate the safety and tolerability of enzastaurin hydrochloride in this patient population.
* To determine whether Gleason score or prior hormonal therapy has any effect on PSA response to treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 6 vs 7 vs 8-10) and prior hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm A:
* Weeks 1-12: Patients are observed without treatment. Patients with a prostate-specific antigen (PSA) rise of \> 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician.
* Weeks 13-44: Patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks.
* Arm B:
* Weeks 1-12: Patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of \> 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician.
* Weeks 13-44: Patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks.
After completion of study treatment, patients are followed every 3 months for 5 years, and then every 6 months for up to 10 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECOG-E1807 | None | None | View |