Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506207
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-23
Brief Title:
A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of S-1 Combined With Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
Status:
UNKNOWN
Status Verified Date:
2007-07
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:
TIROX
Brief Summary:
This study is an open-label single center and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecanoxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma
Detailed Description:
Dose level and escalating schedule are followings
S-1 level 12 34 56 60 70 80 mgm2day every 12-h po on days 1evening-15 morning
Irinotecan level 123 45 6 120 130 140 150 mgm2 mixed in d5w or normal saline 500 ml iv over 90 min on day 1
Oxaliplatin 85 mgm2 fixed dose mixed in d5w 250 ml iv infusion over 2-h on day 1
Treatment will be administered every 3 weeks Start at dose level 1 Thereafter dose level 2 3 4 5 and 6 If dose-limiting toxicity DLT occurs at dose level 1 dose level at -1 will follow
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose-limiting toxicity DLT during treatment cycle 1 At least three patients will be enrolled in each cohort Before escalating to the next dose level all three patients should have received at least one treatment cycle If none of the first three treated patients develops DLT in the first cycle at a specific dose level dose escalation will be continued If one of the first three treated patients develops DLT at any dose level then three additional patients are to be entered on the same dose level If only one in six patients at a given level experiences a DLT escalation will proceed The MTD is defined as the dose level at which at least one-third of patients experienced a DLT The RD for the subsequent phase II study is defined as the preceding dose level before the MTD is attained Intra-patient dose escalation will not be permitted Treatment will be continued in the absence of disease progression or unacceptable toxicity with maximum 12 cycles For purpose of determining the MTD only DLT occurring during the first cycle of therapy will be considered
DLTs are defined as any of following
Grade 4 neutropenia lasting at least 7 days or grade 3 or 4 neutropenia associated with fever 383C as single axillary temperature or 38 C for 1-h
Grade 4 thrombocytopenia
Grade 3 or 4 non-hematological toxicity except alopecia and nauseavomiting
Grade 3 or 4 nauseavomiting not reduced to grade 1 with aggressive antiemetic support
Inability of the patient to take 75 of the planned chemotherapy dose during the treatment period
S-1 level 12 34 56 60 70 80 mgm2day every 12-h po on days 1evening-15 morning
Irinotecan level 123 45 6 120 130 140 150 mgm2 mixed in d5w or normal saline 500 ml iv over 90 min on day 1
Oxaliplatin 85 mgm2 fixed dose mixed in d5w 250 ml iv infusion over 2-h on day 1
Treatment will be administered every 3 weeks Start at dose level 1 Thereafter dose level 2 3 4 5 and 6 If dose-limiting toxicity DLT occurs at dose level 1 dose level at -1 will follow
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose-limiting toxicity DLT during treatment cycle 1 At least three patients will be enrolled in each cohort Before escalating to the next dose level all three patients should have received at least one treatment cycle If none of the first three treated patients develops DLT in the first cycle at a specific dose level dose escalation will be continued If one of the first three treated patients develops DLT at any dose level then three additional patients are to be entered on the same dose level If only one in six patients at a given level experiences a DLT escalation will proceed The MTD is defined as the dose level at which at least one-third of patients experienced a DLT The RD for the subsequent phase II study is defined as the preceding dose level before the MTD is attained Intra-patient dose escalation will not be permitted Treatment will be continued in the absence of disease progression or unacceptable toxicity with maximum 12 cycles For purpose of determining the MTD only DLT occurring during the first cycle of therapy will be considered
DLTs are defined as any of following
Grade 4 neutropenia lasting at least 7 days or grade 3 or 4 neutropenia associated with fever 383C as single axillary temperature or 38 C for 1-h
Grade 4 thrombocytopenia
Grade 3 or 4 non-hematological toxicity except alopecia and nauseavomiting
Grade 3 or 4 nauseavomiting not reduced to grade 1 with aggressive antiemetic support
Inability of the patient to take 75 of the planned chemotherapy dose during the treatment period
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