Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008125
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study Of Gemcitabine Docetaxel And Carboplatin With And Without Filrastim Support Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2016-01
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 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 gemcitabine combined with docetaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of gemcitabine combined with docetaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gemcitabine and docetaxel when administered with carboplatin with or without filgrastim G-CSF in patients with advanced solid tumors II Determine a safe dose level and schedule for this regimen for phase II study in these patients III Determine the toxicity of this regimen in these patients
OUTLINE This is a dose-escalation study of docetaxel and gemcitabine Patients receive gemcitabine IV over 30 minutes docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive gemcitabine IV over 30 minutes on day 8 Treatment repeats every 21 days for approximately 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gemcitabine and 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 DLT If the DLT is grade 4 neutropenia filgrastim G-CSF is added to the regimen administered subcutaneously on days 2-7 and 8-14 or until blood counts recover A new MTD is then determined Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a dose-escalation study of docetaxel and gemcitabine Patients receive gemcitabine IV over 30 minutes docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive gemcitabine IV over 30 minutes on day 8 Treatment repeats every 21 days for approximately 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gemcitabine and 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 DLT If the DLT is grade 4 neutropenia filgrastim G-CSF is added to the regimen administered subcutaneously on days 2-7 and 8-14 or until blood counts recover A new MTD is then determined Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 30 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1884 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068377 | REGISTRY | None | None |
| PCI-IRB-980207 | None | None | None |