Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217477
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2005-09-20
Brief Title:
Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
An Open Label Dose Escalation Study of Paricalcitol Zemplar 19-NOR-1 ALPHA 25-OH D in Combination With Gemcitabine 2 2 -Difluorodeoxycytidine in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2014-12
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 Paricalcitol may cause cancer cells to look more like normal cells and to grow and spread more slowly Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving paricalcitol together with gemcitabine may be an effective treatment for cancer
PURPOSE This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer
PURPOSE This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of paricalcitol when given with gemcitabine in patients with advanced malignancy
Secondary
Determine safety and toxicity of this regimen in these patients
Determine the pharmacokinetics of these regimens in these patients
Determine the clinical outcome overall survival and best overall response of patients treated with this regimen
OUTLINE This is a dose-escalation open-label study
Patients receive gemcitabine IV over 80 minutes on days 1 8 and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1 Beginning in course 2 patients receive paricalcitol IV over 15 minutes on days 1 8 and 15 and gemcitabine IV over 80 minutes on days 2 9 and 16 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A minimum of 6 patients are treated at the MTD
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of paricalcitol when given with gemcitabine in patients with advanced malignancy
Secondary
Determine safety and toxicity of this regimen in these patients
Determine the pharmacokinetics of these regimens in these patients
Determine the clinical outcome overall survival and best overall response of patients treated with this regimen
OUTLINE This is a dose-escalation open-label study
Patients receive gemcitabine IV over 80 minutes on days 1 8 and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1 Beginning in course 2 patients receive paricalcitol IV over 15 minutes on days 1 8 and 15 and gemcitabine IV over 80 minutes on days 2 9 and 16 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A minimum of 6 patients are treated at the MTD
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 44 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