Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003232
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Randomized Placebo-Controlled Trial of MitoxantronePrednisone and Clodronate Versus MitoxantronePrednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain
Status:
COMPLETED
Status Verified Date:
2020-04
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 Some drugs used in chemotherapy can reduce the pain experienced by some people with cancer Combining more than one drug may be more effective at reducing cancer pain It is not known whether receiving combination chemotherapy with clodronate is more effective than receiving combination chemotherapy without clodronate for hormone refractory metastatic prostate cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in treating pain in patients with hormone refractory metastatic prostate cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in treating pain in patients with hormone refractory metastatic prostate cancer
Detailed Description:
OBJECTIVES I Compare the effect of mitoxantrone and prednisone with or without clodronate on localized bone pain in patients with hormone refractory metastatic prostate cancer II Compare the overall survival and quality of life of these patients after these treatments
OUTLINE This is a randomized double blinded placebo controlled multicenter study Patients are stratified according to quality of pain mild vs moderate and previous corticosteroids or one regimen of non-anthracycline-containing cytotoxic chemotherapy eg estramustine vs none Patients are assigned to 1 of 2 treatment arms Arm I consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous clodronate administered over 3 hours every 3 weeks Arm II consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous placebo administered over 3 hours every 3 weeks Doses are adjusted for myelosuppression Treatment continues until disease progression although patients initially on placebo can continue on open-label clodronate or until the maximum cumulative dose of mitoxantrone is reached Patients with a palliative response may continue on prednisone and the study drug clodronate or placebo until disease progression Quality of life is assessed before and every 3 weeks during study treatment A daily pain diary is also maintained All patients are followed at 2 weeks and then every 3 months until death
PROJECTED ACCRUAL This study will accrue 204 patients
OUTLINE This is a randomized double blinded placebo controlled multicenter study Patients are stratified according to quality of pain mild vs moderate and previous corticosteroids or one regimen of non-anthracycline-containing cytotoxic chemotherapy eg estramustine vs none Patients are assigned to 1 of 2 treatment arms Arm I consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous clodronate administered over 3 hours every 3 weeks Arm II consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous placebo administered over 3 hours every 3 weeks Doses are adjusted for myelosuppression Treatment continues until disease progression although patients initially on placebo can continue on open-label clodronate or until the maximum cumulative dose of mitoxantrone is reached Patients with a palliative response may continue on prednisone and the study drug clodronate or placebo until disease progression Quality of life is assessed before and every 3 weeks during study treatment A daily pain diary is also maintained All patients are followed at 2 weeks and then every 3 months until death
PROJECTED ACCRUAL This study will accrue 204 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000066102 | OTHER | PDQ | None |
| CAN-NCIC-PR6 | OTHER | None | None |