CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
DOS2w Dose level 1A +6 moredrug
Likely dose
DOS2w Dose level 1A 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01928524
NCT01928524Phase 1Completed
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Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric

Per Pfeiffer·interventional·Posted Aug 26, 2013·Updated Feb 16, 2021

In Brief

A Phase 1 clinical trial evaluating DOS2w Dose level 1A, DOS2w Dose level 2A, and 5 other interventions for First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFirst-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
CountriesDenmark
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 26, 2013
Enrollment StartSep 1, 2013
Primary CompletionJun 5, 2015
Study CompletionDec 17, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

DOS2w Dose level 1Adrug

Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS2w Dose level 2Adrug

Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS2w Dose level 3Adrug

Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS2w Dose level 4Adrug

Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS3w Dose level 1Bdrug

Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS3w Dose level 2Bdrug

Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.

DOS3w Dose level 3Bdrug

Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.