Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144378
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2005-09-02
Brief Title:
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Randomized Phase III Study With IrinotecanBest Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 25 months There are no data which a possible benefit of second line therapy for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary
Irinotecan shows response rates of 20 in the first line therapy with high rates od disease stabilization There are few trials investigating irinotecan in the second line setting Response rates of 20 are reported in tis setting Irinotecan is supplied without costs from the company Pfizer
Irinotecan shows response rates of 20 in the first line therapy with high rates od disease stabilization There are few trials investigating irinotecan in the second line setting Response rates of 20 are reported in tis setting Irinotecan is supplied without costs from the company Pfizer
Detailed Description:
Metastatic gastric cancer progressive disease after one palliative chemotherapy
Arm A
Irinotecan 250350 mgm2 q3w
1 Cycle250mgm2 30min
2 CycleIf no toxicity2 CTC nor Leuko-thrombopenia3 occured dose is increased to 350mgm2 Arm B Best supportive care
Arm A
Irinotecan 250350 mgm2 q3w
1 Cycle250mgm2 30min
2 CycleIf no toxicity2 CTC nor Leuko-thrombopenia3 occured dose is increased to 350mgm2 Arm B Best supportive care
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