Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005869
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic 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 Gemcitabine HCl in Chemonaive Pancreatic Cancer Patients
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 gemcitabine for pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with gemcitabine in treating patients who have unresectable locally advanced or metastatic pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with gemcitabine in treating patients who have unresectable locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES I Compare the overall survival time to treatment failure clinical benefit response rate analgesic consumption pain intensity performance status and weight change and objective response rate in chemotherapy-naive patients with unresectable locally advanced or metastatic adenocarcinoma of the pancreas treated with oral nitrocamptothecin vs gemcitabine II Compare the toxicity of these 2 regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to measurable disease yes vs no Karnofsky performance status 50-70 vs 70-100 and prior radiotherapy Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral nitrocamptothecin on days 1-5 Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after week 8 may receive additional courses Arm II Patients receive gemcitabine IV over 30 minutes on day 1 Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity Patients then undergo 1 week of rest Patients with stable or responding disease after week 8 may receive gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 4 weeks Pain is assessed within 7 days prior to study at days 28 and 56 during study and then every 28 days after completion of study Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 994 patients 497 per arm will be accrued for this study within 22 months
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to measurable disease yes vs no Karnofsky performance status 50-70 vs 70-100 and prior radiotherapy Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral nitrocamptothecin on days 1-5 Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after week 8 may receive additional courses Arm II Patients receive gemcitabine IV over 30 minutes on day 1 Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity Patients then undergo 1 week of rest Patients with stable or responding disease after week 8 may receive gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 4 weeks Pain is assessed within 7 days prior to study at days 28 and 56 during study and then every 28 days after completion of study Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 994 patients 497 per arm will be accrued for this study within 22 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 |
|---|---|---|---|
| SUPERGEN-RFS2000-02 | None | None | None |