Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021346
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2001-07-11
Brief Title:
Carboplatin and Gemcitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Evaluation Of Carboplatin And Gemcitabine
Status:
COMPLETED
Status Verified Date:
2013-04
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gemcitabine and carboplatin in patients with advanced solid tumors II Determine the dose-limiting toxic effects of this regimen in these patients III Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients IV Determine the observed responses in these patients receiving this regimen
OUTLINE This is a dose-escalation study of gemcitabine Patients are stratified according to prior therapy no prior chemotherapy andor prior radiotherapy to less than 20 of bone marrow vs prior chemotherapy andor prior radiotherapy to at least 20 of bone marrow Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 1-3 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity Patients are followed for survival
PROJECTED ACCRUAL A maximum of 18 patients 9 per stratum will be accrued for this study
OUTLINE This is a dose-escalation study of gemcitabine Patients are stratified according to prior therapy no prior chemotherapy andor prior radiotherapy to less than 20 of bone marrow vs prior chemotherapy andor prior radiotherapy to at least 20 of bone marrow Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 1-3 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity Patients are followed for survival
PROJECTED ACCRUAL A maximum of 18 patients 9 per stratum 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-G01-1984 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-97028 | None | None | None |