Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016913
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-06-06
Brief Title:
Chemotherapy Hormone Therapy and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study Of Neo-Adjuvant Paclitaxel Estramustine And Carboplatin TEC Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Androgens can stimulate the growth of prostate cancer cells Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy hormone therapy and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer
PURPOSE This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer
Detailed Description:
OBJECTIVES
Determine the feasibility and safety of paclitaxel estramustine carboplatin and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer
Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour once weekly oral estramustine three times a day five days a week and carboplatin IV over 1 hour once monthly Treatment repeats every 4 weeks for 4 courses
Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly Treatment repeats every 4 weeks for 6 courses
After the completion of chemotherapy patients undergo radiotherapy once daily on weeks 17-24
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 15 years
Determine the feasibility and safety of paclitaxel estramustine carboplatin and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer
Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 1 hour once weekly oral estramustine three times a day five days a week and carboplatin IV over 1 hour once monthly Treatment repeats every 4 weeks for 4 courses
Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly Treatment repeats every 4 weeks for 6 courses
After the completion of chemotherapy patients undergo radiotherapy once daily on weeks 17-24
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-99811 | None | None | None |
| CDR0000068632 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |