Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019474
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Phase II Trial of 2-Fluorouracil Recombinant Alpha-2a-Interferon and Intravenous Hydroxyurea With Filgrastim in Patients With Refractory GI Malignancies Grant Application Title Parenteral Hydroxyurea A Modulator in Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
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 Interferon alfa may interfere with the growth of cancer cells Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person recover from the side effects of chemotherapy Combining chemotherapy with interferon alfa may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and interferon alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and interferon alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer
Detailed Description:
OBJECTIVES I Determine the objective response rates in patients with unresectable locally advanced or advanced gastrointestinal malignancy treated with intravenous hydroxyurea fluorouracil interferon alfa and filgrastim G-CSF II Determine the toxic effects of this regimen in these patients III Determine the reversal of toxic effects of this regimen in these patients
OUTLINE Patients are stratified according to site of primary disease hepatobiliary vs gastric vs pancreatic Patients receive fluorouracil IV over 48 hours and hydroxyurea IV over 48 hours on days 1 8 22 and 29 Patients also receive interferon alfa subcutaneously SC on days 1 3 and 5 and filgrastim G-CSF SC on days 3-6 of weeks 1 2 4 and 5 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 31-60 patients 18-33 with hepatobiliary or gastric cancer and 13-27 with pancreatic cancer will be accrued for this study
OUTLINE Patients are stratified according to site of primary disease hepatobiliary vs gastric vs pancreatic Patients receive fluorouracil IV over 48 hours and hydroxyurea IV over 48 hours on days 1 8 22 and 29 Patients also receive interferon alfa subcutaneously SC on days 1 3 and 5 and filgrastim G-CSF SC on days 3-6 of weeks 1 2 4 and 5 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 31-60 patients 18-33 with hepatobiliary or gastric cancer and 13-27 with pancreatic cancer 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 |
|---|---|---|---|
| MMC-FDR001009-PHII | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |
| P30CA013330 | NIH | None | None |
| AECM-9707254 | None | None | None |
| MMC-9007262-PHII | None | None | None |