Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348816
Status:
TERMINATED
Last Update Posted:
2017-12-08
First Post:
2006-07-05
Brief Title:
Docetaxel Radiation Therapy and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Docetaxel may make tumor cells more sensitive to radiation therapy Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer
PURPOSE This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the rate of prostate-specific antigen PSA decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy
Secondary
Determine the tolerability of this regimen in these patients
Determine the progression-free survival based on PSA progression of these patients
Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy
Determine if the velocity of subsequent PSA failure impacts survival of these patients
Tertiary
Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy
Quaternary To collect data on a contemporary cohort to those on study that received radiation alone We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes
OUTLINE Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 36 and 43 and undergo external-beam radiotherapy on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47
Beginning within 6 weeks after completion of chemoradiotherapy patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the rate of prostate-specific antigen PSA decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy
Secondary
Determine the tolerability of this regimen in these patients
Determine the progression-free survival based on PSA progression of these patients
Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy
Determine if the velocity of subsequent PSA failure impacts survival of these patients
Tertiary
Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy
Quaternary To collect data on a contemporary cohort to those on study that received radiation alone We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes
OUTLINE Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 36 and 43 and undergo external-beam radiotherapy on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47
Beginning within 6 weeks after completion of chemoradiotherapy patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| HSC20050377H | OTHER | UTHSCSA IRB | None |