Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084825
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2004-06-10
Brief Title:
Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases Extension Trial to ID03-0008
Status:
COMPLETED
Status Verified Date:
2012-10
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 such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving docetaxel with imatinib mesylate may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008
PURPOSE This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008
Detailed Description:
OBJECTIVES
Primary
Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008
Secondary
Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate
Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient
Determine the quality of life of patients treated with this crossover regimen
OUTLINE This is an open-label crossover multicenter extension study Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate
Patients receive docetaxel IV over 1 hour on days 1 8 15 and 22 and oral imatinib mesylate once daily on days 1-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each therapy course and at the completion of therapy
Patients are followed for 30 days
PROJECTED ACCRUAL A maximum of 72 patients will be accrued for this study within 9 months
Primary
Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008
Secondary
Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate
Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient
Determine the quality of life of patients treated with this crossover regimen
OUTLINE This is an open-label crossover multicenter extension study Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate
Patients receive docetaxel IV over 1 hour on days 1 8 15 and 22 and oral imatinib mesylate once daily on days 1-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each therapy course and at the completion of therapy
Patients are followed for 30 days
PROJECTED ACCRUAL A maximum of 72 patients will be accrued for this study within 9 months
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 |
|---|---|---|---|
| ID03-0222 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-ID-030222 | None | None | None |
| MSKCC-03149 | None | None | None |