Clinical trial NCT01928524
Conditions: First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Keywords: Gastric cancer Cancer of the esophagus Oxaliplatin Docetaxel S1
Sponsor: Per Pfeiffer
Start date: 2013-09-01; Completion date: 2015-12-17
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief 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.

Detailed description:
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).

Methods:

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.

Arms: arm 1: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. arm 2: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. arm 3: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. arm 4: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. arm 5: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. arm 6: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. arm 7: Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Interventions: intervention 1: DOS2w Dose level 1A intervention 2: DOS2w Dose level 2A intervention 3: DOS2w Dose level 3A intervention 4: DOS2w Dose level 4A intervention 5: DOS3w Dose level 1B intervention 6: DOS3w Dose level 2B intervention 7: DOS3w Dose level 3B
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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. intervention 6: 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. intervention 7: 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.

Protocol documents: