Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003884
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
1999-11-01
Brief Title:
Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Trial to Evaluate the Safety and Efficacy of Zoledronate 4 and 8 mg Administered Intravenously as an Adjuvant to Anticancer Therapy to Patients With Any Cancer With Bone Metastases Other Than Breast Cancer Multiple Myeloma or Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 Zoledronate may help to relieve some of the symptoms caused by bone metastases It is not yet known if zoledronate is more effective than no further therapy in relieving symptoms of bone metastases or preventing disease progression
PURPOSE Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone
PURPOSE Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone
Detailed Description:
OBJECTIVES I Assess the safety and efficacy of zoledronate in patients with any solid tumor cancer with bone metastases other than breast or prostate cancer II Assess the efficacy of zoledronate in preventing skeletal-related events including tumor induced hypercalcemia TIH time to first occurrence of skeletal-related event or TIH skeletal morbidity rate time to progression of bone metastases overall survival and time to overall disease progression in these patients III Assess the quality of life and pain in these patients on these regimens
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified into two groups patients with lung cancer and patients with all other solid tumor cancers Patients are randomly assigned to receive 1 of the following treatments Arm I Patients receive intravenous zoledronate over 5 minutes every 3 weeks for 9 months Arm II Patients receive intravenous zoledronate at a higher dose over 5 minutes every 3 weeks for 9 months Arm III Patients receive intravenous placebo over 5 minutes every 3 weeks for 9 months All patients receive oral calcium daily and an oral multivitamin supplement Quality of life is assessed prior to therapy then at months 3 6 and 9 Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 600 patients will be accrued for this study within 12 months
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified into two groups patients with lung cancer and patients with all other solid tumor cancers Patients are randomly assigned to receive 1 of the following treatments Arm I Patients receive intravenous zoledronate over 5 minutes every 3 weeks for 9 months Arm II Patients receive intravenous zoledronate at a higher dose over 5 minutes every 3 weeks for 9 months Arm III Patients receive intravenous placebo over 5 minutes every 3 weeks for 9 months All patients receive oral calcium daily and an oral multivitamin supplement Quality of life is assessed prior to therapy then at months 3 6 and 9 Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 600 patients will be accrued for this study within 12 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 |
|---|---|---|---|
| NOVARTIS-4244603011 | None | None | None |