Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019513
Status:
COMPLETED
Last Update Posted:
2012-03-23
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent Refractory or Metastatic Solid Tumors or Lymphomas
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-03
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining gemcitabine fluorouracil and leucovorin in treating patients with recurrent refractory or metastatic solid tumors or lymphomas
PURPOSE Phase I trial to study the effectiveness of combining gemcitabine fluorouracil and leucovorin in treating patients with recurrent refractory or metastatic solid tumors or lymphomas
Detailed Description:
OBJECTIVES
Determine the clinical toxic effects associated with administering sequential gemcitabine followed by fluorouracil with leucovorin calcium in patients with refractory or recurrent or metastatic solid tumors or lymphomas
Determine achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients
Determine any antitumor activity of this regimen in these patients
Determine the pharmacodynamics of gemcitabine and fluorouracil in these patients
OUTLINE This is a dose-escalation study of fluorouracil and gemcitabine
During the first course patients receive gemcitabine IV over 30 minutes once weekly for 2 weeks followed by one week of rest During subsequent courses patients receive gemcitabine as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of fluorouracil is followed by sequential dose escalation of gemcitabine Cohorts of 3-6 patients receive escalating doses of fluorouracil and then gemcitabine until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 108 patients will be accrued for this study
Determine the clinical toxic effects associated with administering sequential gemcitabine followed by fluorouracil with leucovorin calcium in patients with refractory or recurrent or metastatic solid tumors or lymphomas
Determine achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients
Determine any antitumor activity of this regimen in these patients
Determine the pharmacodynamics of gemcitabine and fluorouracil in these patients
OUTLINE This is a dose-escalation study of fluorouracil and gemcitabine
During the first course patients receive gemcitabine IV over 30 minutes once weekly for 2 weeks followed by one week of rest During subsequent courses patients receive gemcitabine as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of fluorouracil is followed by sequential dose escalation of gemcitabine Cohorts of 3-6 patients receive escalating doses of fluorouracil and then gemcitabine until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 108 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066587 | None | None | None |
| 98-C-0143 | None | None | None |