Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017576
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2001-06-06
Brief Title:
Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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 Calcitriol may help carboplatin kill more cancer cells by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the response in patients with androgen-independent prostate cancer treated with calcitriol and carboplatin II Determine the palliative response in patients with cancer-related pain treated with this regimen III Determine the response in patients with bidimensionally measurable disease treated with this regimen IV Determine the duration of prostate-specific antigen palliative and measurable disease responses in patients treated with this regimen V Determine the survival of patients treated with this regimen VI Assess the quality of life of patients treated with this regimen VII Determine the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day 2 Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline and then every 4 weeks until disease progression Patients are followed every 4 weeks until disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 18-36 patients will be accrued for this study
OUTLINE Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day 2 Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline and then every 4 weeks until disease progression Patients are followed every 4 weeks until disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 18-36 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 |
|---|---|---|---|
| OHSU-6218 | None | None | None |
| OHSU-HOR-00059-L | None | None | None |
| NCI-G01-1963 | None | None | None |