Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001428
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2000-01
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:
This protocol will evaluate the activity of 5-Fluorouracil FUra given as a 1 hour infusion in combination with leucovorin LV and interferon IFN alpha-2a in patients with advanced measurable colorectal cancer
Detailed Description:
This protocol will evaluate the activity of 5-Fluorouracil FUra given as a 1 hour infusion in combination with leucovorin LV and interferon IFN alpha-2a in patients with advanced measurable colorectal cancer IFN alpha-2a will be given at 5 million Um2 SC days 1-6 LV 200 mgm2 will be given as a short infusion over 30 minutes days 2-6 followed immediately by a 1 hour IV infusion of FUra days 2-6 The starting dose of FUra will be 425 mgm2d1 Cycles will be repeated at three week intervals provided that the granulocyte count and platelet count have recovered to gte 1200microL and gte 80000microL respectively and all non-hematologic toxicity has resolved The dose of FUra will be adjusted according to individual tolerance Preliminary experience with FUra given as a 1 hour infusion suggests that it is less toxic The primary goal of this study is to determine if this less toxic regimen retains clinical antitumor activity FUra plasma samples will be obtained the initial cycle at 50 and 55 minutes during the first 1 hour infusion of FUra to permit documentation of achieved plasma levels and to permit correlation between FUra pharmacokinetics and clinical toxicity andor response Pharmacokinetic sampling will be repeated if the dose of FUra is increased or decreased in subsequent cycles
Patients will be stratified according to whether or not they have received prior adjuvant chemotherapy A two-stage design will be employed for patients with no prior chemotherapy If less than or equal to 4 responses are seen among the initial 20 previously untreated patients accrual will cease If greater than or equal to 5 responses are seen in the initial 20 patients however accrual will be expanded to 40 patients
Fourteen patients who have received prior adjuvant chemotherapy completing it at least 6 months prior to study entry or have received prior FUra only as a radiation sensitizer will be entered If no responses are seen accrual to this cohort will cease If greater than or equal to 1 response is seen accrual may be expanded to 24 patients
Patients will be stratified according to whether or not they have received prior adjuvant chemotherapy A two-stage design will be employed for patients with no prior chemotherapy If less than or equal to 4 responses are seen among the initial 20 previously untreated patients accrual will cease If greater than or equal to 5 responses are seen in the initial 20 patients however accrual will be expanded to 40 patients
Fourteen patients who have received prior adjuvant chemotherapy completing it at least 6 months prior to study entry or have received prior FUra only as a radiation sensitizer will be entered If no responses are seen accrual to this cohort will cease If greater than or equal to 1 response is seen accrual may be expanded to 24 patients
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 |
|---|---|---|---|
| 95-C-0067 | None | None | None |