Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014456
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Dose-Escalation Trial Of The Combination Of Docetaxel Gemcitabine And Filgrastim NEUPOGEN For The Treatment Of Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-08
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 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 plus filgrastim in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and filgrastim G-CSF in patients with advanced solid tumors
Determine the dose-limiting toxicity associated with this regimen in these patients
Assess the objective anti-tumor response in patients treated with this regimen
Determine fatigue and blood cytokines in patients treated with this regimen
OUTLINE This is a dose-escalation study of docetaxel
Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts recover Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel 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
Fatigue is assessed at baseline and then at weeks 2 5 7 and 9 during therapy
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 15-22 months
Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and filgrastim G-CSF in patients with advanced solid tumors
Determine the dose-limiting toxicity associated with this regimen in these patients
Assess the objective anti-tumor response in patients treated with this regimen
Determine fatigue and blood cytokines in patients treated with this regimen
OUTLINE This is a dose-escalation study of docetaxel
Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts recover Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel 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
Fatigue is assessed at baseline and then at weeks 2 5 7 and 9 during therapy
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 15-22 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-G01-1933 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |
| DMS-9933 | None | None | None |