Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003294
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine
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 side effects of chemotherapy Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of paclitaxel plus carboplatin given with amifostine and filgrastim in treating patients with recurrent or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of paclitaxel plus carboplatin given with amifostine and filgrastim in treating patients with recurrent or metastatic cancer
Detailed Description:
OBJECTIVES I Establish the maximum tolerated dose of a paclitaxel and carboplatin combination modulated by amifostine and filgrastim G-CSF in patients with recurrent or metastatic cancer II Define the dose limiting toxicity of this combination in these patients III Observe any antitumor responses in patients treated with this combination
OUTLINE This is a dose escalation study of paclitaxel Patients receive a 10 minute infusion of amifostine followed by paclitaxel given intravenously over 3 hours followed by carboplatin given over 30 minutes Filgrastim G-CSF is given subcutaneously daily for up to 10 days by self administration starting the following day Treatment repeats every 28 days for at least 3 courses unless disease progression or unacceptable toxicity occurs Patients who develop dose-limiting toxicity DLT on a given course receive one dose level lower on the next and subsequent courses Patients with stable disease may continue treatment for as long as benefit is shown In the absence of DLT in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of paclitaxel on the same schedule If DLT occurs in 1 of 3 patients at a given dose level then 3 additional patients are added at that dose If DLT occurs in 1 additional patient this dose is the maximum tolerated dose MTD if DLT occurs in more than 2 patients then 3 additional patients are added at the previous dose If DLT occurs in no more than 2 of 6 patients this dose is considered the MTD At any dose 3 cases of DLT leads to discontinuation of recruitment at that dose
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study of paclitaxel Patients receive a 10 minute infusion of amifostine followed by paclitaxel given intravenously over 3 hours followed by carboplatin given over 30 minutes Filgrastim G-CSF is given subcutaneously daily for up to 10 days by self administration starting the following day Treatment repeats every 28 days for at least 3 courses unless disease progression or unacceptable toxicity occurs Patients who develop dose-limiting toxicity DLT on a given course receive one dose level lower on the next and subsequent courses Patients with stable disease may continue treatment for as long as benefit is shown In the absence of DLT in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of paclitaxel on the same schedule If DLT occurs in 1 of 3 patients at a given dose level then 3 additional patients are added at that dose If DLT occurs in 1 additional patient this dose is the maximum tolerated dose MTD if DLT occurs in more than 2 patients then 3 additional patients are added at the previous dose If DLT occurs in no more than 2 of 6 patients this dose is considered the MTD At any dose 3 cases of DLT leads to discontinuation of recruitment at that dose
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| NCI-G98-1410 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |
| RPCI-DS-97-14 | None | None | None |