Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03162510 |
Other study ID # |
TCOG T1216 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
June 26, 2018 |
Est. completion date |
January 31, 2022 |
Study information
Verified date |
June 2021 |
Source |
National Health Research Institutes, Taiwan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The primary purpose of the study is to determine the maximal tolerated dose (MTD) of
Oxaliplatin in this phase I study. The secondary objectives are to determine the response
rate, progression free survival, overall survival, and safety profiles.
Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel
(Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus
oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till
disease progression.
Description:
Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel
(Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus
oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till
disease progression.
In this study (a standard 3 x 3 design), patients will be enrolled in cohort of 3 to receive
escalating dose of Oxaliplatin at three dose levels (level I, 60 mg/m2, level II, 75 mg/m2
and level III, 85 mg/m2). Intra-patient dose escalation will not be allowed. If none of the
first 3 patients of a cohort experiences a dose limiting toxicity (DLT), then dose escalation
will proceed for next cohort of patients. If 1 of 3 patients developed DLT, the cohort will
be expanded to 6 patients. If ≤2 patients of the 6 patients experience DLT, then dose
escalation will proceed in next study cohort unless 85 mg/m2 have reached. If 2 of the first
3 or ≥3 of 6 patients developed DLT at certain dose level, then dose escalation will be
withheld and the prior dose level will be the maximum tolerated dose (MTD). A minimum of 6
evaluable patients will be treated at the MTD dose level with no more than 2 of the 6
patients having DLT at this dose level. The MTD will be considered as the recommended dose
for future Phase II studies. The number of patient accrual will range from 12 and 18 (6/dose
level) evaluable patients in the dose-finding stage to determine the MTD of Oxaliplatin in
this combination regimen.
Of patients who experience grade 2 sensory neuropathy after the triplet chemotherapy,
Oxaliplatin will be omitted (only nab-paclitaxel plus S-1/LV will be continued) until the
recovery of sensory neuropathy to grade 1 or less then Oxaliplatin will be re-instituted.
CBC/DC, AST/ALT and BUN/Cr will be determined at baseline and every 2 weeks during study
period. Serum level of albumin, bilirubin (T), LDH, Alk-P/GGT, Na/K/Mg/Ca/P and CRP will be
determined at baseline and every 4 weeks during the treatment. Radiographic objective tumor
response assessment, according to RECIST version 1.1, by CT scan or MRI at baseline, and then
every 6 weeks during the study period. Tumor marker, CEA and CA 19-9, will be evaluated at
baseline and every 4 weeks during the treatment.