Chemotherapy for Patients With Cancer of the Stomach (DOS)
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|ClinicalTrials.gov Identifier: NCT01928524|
Recruitment Status : Completed
First Posted : August 26, 2013
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or||Drug: DOS2W Drug: DOS3W||Phase 1|
The primary aim of this dose-finding study is to determine the maximum tolerated doses of docetaxel, oxaliplatin and S1 given every second (DOS2w) or third (DOS3w) week as first-line treatment in patients with advanced gastro-esophageal cancer. Secondary end points are to evaluate toxicities according to NCI-CTCAE v. 4, response rate, progression-free survival and overall survival
Primary Outcome Measure:
To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).
The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).
This dose-finding study is planned to include a total of 24 patients with advanced gastro-esophageal cancer, adenocarcinoma.
12 patients will be included in (DOS2w) at four at progressively higher dose levels.
Chemotherapy will be repeated day 1 every second week to a maximum of nine courses.
12 patients will be included in (DOS3w) at three progressively higher dose levels.
Chemotherapy will be repeated day 1 every third week to a maximum of six courses.
In both (DOS2w) and (DOS3w) dose-limiting toxicity (DLT) will be evaluated after the first course. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continues if 0/3 or 1/6 patients experience DLT.
Patients will be evaluated with a ct-scan at baseline and after every three or four cycles to exclude progression and evaluate response. Response is assessed by the investigator according to RECIST version 1.1.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 5, 2015|
|Actual Study Completion Date :||December 17, 2015|
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.
Docetaxel (30-35 mg/m2), Oxaliplatin (70 mg/m2) and S1 (30-50 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.
Docetaxel (25 mg/m2), Oxaliplatin (100 mg/m2) and S1 (40-60 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered
- Maximum tolerable dose (MTD) [ Time Frame: 2-3 weeks after first administration of DOS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928524
|Odense University Hospital|
|Odense, Denmark, 5000|
|Study Chair:||Per Pfeiffer, Professor||Odense University Hospital|