Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005871
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of RFS 2000 9-Nitro-Camptothecin 9-NC Versus 5-Fluorouracil 5-FU in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine
Detailed Description:
OBJECTIVES I Compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil II Compare the clinical benefit and objective response rate to these treatment regimens in these patients III Compare and evaluate time to treatment failure in these patients with these treatment regimens IV Compare the toxicities of these treatment regimens in these patients
OUTLINE This is a randomized open label multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive nitrocamptothecin orally on days 1-5 Arm II Patients receive fluorouracil IV over 30 minutes on day 1 Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity Patients with tumor regression or stabilization may receive additional courses of treatment Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm Patients are followed every 3 months for one year
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 15 months
OUTLINE This is a randomized open label multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive nitrocamptothecin orally on days 1-5 Arm II Patients receive fluorouracil IV over 30 minutes on day 1 Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity Patients with tumor regression or stabilization may receive additional courses of treatment Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm Patients are followed every 3 months for one year
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 15 months
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 |
|---|---|---|---|
| PCI-99-001 | None | None | None |
| SUPERGEN-RFS2000-06 | None | None | None |