Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084708
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2004-06-10
Brief Title:
Calcitriol and Gefitinib With or Without Dexamethasone in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of Intravenous IV Calcitriol in Combination With ZD1839 IRESSA in Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
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 Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Calcitriol may help tumor cells develop into normal cells Dexamethasone may increase the effectiveness and decrease the side effects of gefitinib and calcitriol
PURPOSE This phase I trial is studying the side effects and best dose of calcitriol when given together with gefitinib or when given together with gefitinib and dexamethasone in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of calcitriol when given together with gefitinib or when given together with gefitinib and dexamethasone in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD toxic effects and tolerability of calcitriol alone and in combination with gefitinib with or without dexamethasone in patients with advanced solid tumors
Secondary
Determine the pharmacokinetics and pharmacodynamics of these regimens in these patients
Determine any tumor responses in patients treated with these regimens
OUTLINE This is a dose-escalation study of calcitriol
Stage 1 Patients receive calcitriol IV over 1 hour on days 1 15 and 22 and oral gefitinib once daily on days 8-28 during course 1 For all subsequent courses patients receive calcitriol IV over 1 hour on days 1 8 15 and 22 and oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of calcitriol with a fixed dose of gefitinib 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
Stage 2 Patients receive calcitriol beginning at 1 dose level below the MTD determined in stage 1 and gefitinib as in stage 1 Patients also receive oral dexamethasone once on the day before and twice on the day of each dose of calcitriol
Cohorts 3-6 patients receive escalating doses of calcitriol with fixed doses of gefitinib and dexamethasone until the 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
PROJECTED ACCRUAL A total of 21-36 patients will be accrued for this study within 1 year
Primary
Determine the maximum tolerated dose MTD toxic effects and tolerability of calcitriol alone and in combination with gefitinib with or without dexamethasone in patients with advanced solid tumors
Secondary
Determine the pharmacokinetics and pharmacodynamics of these regimens in these patients
Determine any tumor responses in patients treated with these regimens
OUTLINE This is a dose-escalation study of calcitriol
Stage 1 Patients receive calcitriol IV over 1 hour on days 1 15 and 22 and oral gefitinib once daily on days 8-28 during course 1 For all subsequent courses patients receive calcitriol IV over 1 hour on days 1 8 15 and 22 and oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of calcitriol with a fixed dose of gefitinib 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
Stage 2 Patients receive calcitriol beginning at 1 dose level below the MTD determined in stage 1 and gefitinib as in stage 1 Patients also receive oral dexamethasone once on the day before and twice on the day of each dose of calcitriol
Cohorts 3-6 patients receive escalating doses of calcitriol with fixed doses of gefitinib and dexamethasone until the 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
PROJECTED ACCRUAL A total of 21-36 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| RPCI-RPC-0207 | None | None | None |