Viewing Study NCT00080678



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Study NCT ID: NCT00080678
Status: COMPLETED
Last Update Posted: 2012-10-12
First Post: 2004-04-07

Brief Title: Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Sponsor: MD Anderson Cancer Center
Organization: MD Anderson Cancer Center

Study Overview

Official Title: Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer AIPC With Bone Metastases
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 Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases

PURPOSE This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases
Detailed Description: OBJECTIVES

Primary

Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate

Secondary

Compare the response rates in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare quality of life of patients treated with these regimens

OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to hemoglobin 11gdL vs 11 gdL alkaline phosphatase normal vs elevated number of prior regimens 0 vs 1 or 2 and ECOG performance score 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms

Arm I Patients receive docetaxel IV on days 1 8 15 and 22 and oral imatinib mesylate once daily on days 1-43
Arm II Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43

In both arms courses repeat every 43 days in the absence of disease progression or unacceptable toxicity Patients who progress on arm II may cross over to arm I

PROJECTED ACCRUAL A total of 152 patients 76 per treatment arm 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
DFCI-03187 None None None
MDA-ID-030008 None None None
NOVARTIS-MDA-ID-030008 None None None
MSKCC-03132 None None None