Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027859
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2001-12-07
Brief Title:
Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy KetoconazoleHydrocortisone Versus PaclitaxelEstramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 stimulate the growth of prostate cancer cells Drugs such as ketoconazole may stop the production of androgens Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression
Detailed Description:
OBJECTIVES
Compare time to objective progression in patients with prostate cancer and a rising prostate-specific antigen PSA after androgen suppression when treated with second-line hormonal therapy ketoconazole and hydrocortisone vs combination chemotherapy docetaxel and estramustine
Compare time to PSA progression and correlate this with time to objective progression in patients treated with these regimens
Compare the quality of life in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare the natural history of progression in patients treated with these regimens
Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of apoptopic biomarkers in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior treatment with bisphosphonates yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral estramustine three times daily on days 1-5 and docetaxel IV over 1 hour on day 2 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of week 9 at 6 months and 1 year and then annually for up to 10 years or until beginning of first non-protocol therapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 590 patients 295 per treatment arm will be accrued for this study within 4 years
Compare time to objective progression in patients with prostate cancer and a rising prostate-specific antigen PSA after androgen suppression when treated with second-line hormonal therapy ketoconazole and hydrocortisone vs combination chemotherapy docetaxel and estramustine
Compare time to PSA progression and correlate this with time to objective progression in patients treated with these regimens
Compare the quality of life in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare the natural history of progression in patients treated with these regimens
Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of apoptopic biomarkers in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to prior treatment with bisphosphonates yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral estramustine three times daily on days 1-5 and docetaxel IV over 1 hour on day 2 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of week 9 at 6 months and 1 year and then annually for up to 10 years or until beginning of first non-protocol therapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 590 patients 295 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CALGB-E1899 | None | None | None |
| E1899 | None | None | None |
| SWOG-E1899 | None | None | None |