Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005870
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
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 Most Appropriate Therapy in Refractory 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 other chemotherapy for cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of other chemotherapy in treating patients who have recurrent or refractory cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of other chemotherapy in treating patients who have recurrent or refractory cancer of the pancreas
Detailed Description:
OBJECTIVES I Compare the overall survival objective response rate time to treatment failure and time to progression in patients with recurrent or refractory adenocarcinoma of the pancreas treated with oral nitrocamptothecin vs most appropriate chemotherapy II Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to Karnofsky performance status 50-70 vs greater than 70 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 are stratified according to most appropriate therapy possible mitomycin or investigators choice including best supportive care vs gemcitabine vs fluorouracil Patients who previously received fluorouracil and gemcitabine with or without radiotherapy receive mitomycin or the investigators choice of any proven or experimental chemotherapy regimen previously submitted to the sponsor Patients who previously received fluorouracil only other chemotherapy only or fluorouracil with other chemotherapy receive a proven or experimental regimen comprising gemcitabine Patients who previously received gemcitabine with other chemotherapy receive a proven or experimental regimen comprising fluorouracil Patients with stable or responding disease after week 8 may receive additional courses if medically indicated Patients for whom these drugs are not indicated may receive best supportive care At the time of disease progression patients may receive treatment with nitrocamptothecin Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 400 patients 200 per arm will be accrued for this study within 15 months
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to Karnofsky performance status 50-70 vs greater than 70 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 are stratified according to most appropriate therapy possible mitomycin or investigators choice including best supportive care vs gemcitabine vs fluorouracil Patients who previously received fluorouracil and gemcitabine with or without radiotherapy receive mitomycin or the investigators choice of any proven or experimental chemotherapy regimen previously submitted to the sponsor Patients who previously received fluorouracil only other chemotherapy only or fluorouracil with other chemotherapy receive a proven or experimental regimen comprising gemcitabine Patients who previously received gemcitabine with other chemotherapy receive a proven or experimental regimen comprising fluorouracil Patients with stable or responding disease after week 8 may receive additional courses if medically indicated Patients for whom these drugs are not indicated may receive best supportive care At the time of disease progression patients may receive treatment with nitrocamptothecin Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 400 patients 200 per 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 |
|---|---|---|---|
| RPCI-DS-99-11 | None | None | None |
| SUPERGEN-RFS2000-09 | None | None | None |