Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003144
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-11-01
Brief Title:
Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase I Study of Amifostine Ethyol as a Cytoprotector of GemcitabineCisplatin Combination
Status:
COMPLETED
Status Verified Date:
2011-03
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 use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the bad side effects of chemotherapy
PURPOSE Randomized phase I trial to study the effectiveness of amifostine in treating patients who are receiving chemotherapy for recurrent or refractory solid tumors
PURPOSE Randomized phase I trial to study the effectiveness of amifostine in treating patients who are receiving chemotherapy for recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Evaluate the ability of amifostine to facilitate increased dose escalation of gemcitabine and cisplatin II Compare the dose limiting toxicities of gemcitabine and cisplatin administered with and without amifostine in these patients III Determine the maximum tolerated dose of gemcitabine and cisplatin administered with amifostine in these patients IV Determine whether synergy is produced by administering gemcitabine and cisplatin on the same day
OUTLINE This is a two stage study The first stage is a randomized study and the second stage is a dose escalation study In the first stage of the study patients receive either intravenous gemcitabineamifostinecisplation GAP or gemcitabinecisplatin GP in the first cycle Patients are administered the other arm in the second cycle In the second stage of the study dose escalation the initial dose of GP or GAP is given on days 1 and 8 every 28 days Dose escalation is carried out in cohorts of 3 patients per dose level If 1 of 3 patients experiences dose limiting toxicity DLT then 3 more patients are accrued at the same dose level The maximum tolerated dose MTD is defined as the lowest dose at which 2 of 6 or 2 of 3 patients experience DLT Patients experiencing grade 3 or 4 toxicity or tumor progression are removed from the study Patients will be reassessed every 12 weeks
PROJECTED ACCRUAL A total of 32 patients will be accrued over 12-24 months in the first stage of this study and 9-12 patients will be accrued for the second stage
OUTLINE This is a two stage study The first stage is a randomized study and the second stage is a dose escalation study In the first stage of the study patients receive either intravenous gemcitabineamifostinecisplation GAP or gemcitabinecisplatin GP in the first cycle Patients are administered the other arm in the second cycle In the second stage of the study dose escalation the initial dose of GP or GAP is given on days 1 and 8 every 28 days Dose escalation is carried out in cohorts of 3 patients per dose level If 1 of 3 patients experiences dose limiting toxicity DLT then 3 more patients are accrued at the same dose level The maximum tolerated dose MTD is defined as the lowest dose at which 2 of 6 or 2 of 3 patients experience DLT Patients experiencing grade 3 or 4 toxicity or tumor progression are removed from the study Patients will be reassessed every 12 weeks
PROJECTED ACCRUAL A total of 32 patients will be accrued over 12-24 months in the first stage of this study and 9-12 patients will be accrued for the second stage
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 |
|---|---|---|---|
| NCI-V97-1363 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9722 | None | None | None |
| ALZA-97-011-ii | None | None | None |