Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Oxaliplatin

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.

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 1A

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 2A

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 3A

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.

DOS2w Dose level 4A

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 1B

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 2B

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.

DOS3w Dose level 3B

Per Pfeiffer, Professor

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.

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.

Two parallel phase 1/2a studies with 3+3 design with either DOS given every second week or every third week in Caucasian patients (Table 1). Patients were included into DOS2w and DOS3w in sequence.

In the DOS2w group: Patients received escalating doses of Docetaxel (30-50 mg/m2 on Day 1), fixed doses of O (70 mg/ m2 on Day 1) and S-1 (30-35 mg/m2/day twice daily orally on Days 1-7) every two weeks. In the DOS3w group: Patients received escalating doses of docetaxel (40-60 mg/m2 on Day 1), fixed doses of O (100 mg/ m2 on Day 1) and S-1 (25 mg/m2/day twice daily orally on Days 1-14) every three weeks.

Chemotherapy for Patients With Cancer of the Stomach

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

Professor

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS2w Dose Level 1A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS2w Dose Level 2A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2w: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS2w Dose Level 3A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2w: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS2w Dose Level 4A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3w: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS3w Dose Level 1B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS3w: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS3w Dose Level 2B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS3w: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week.

Dose levels are described in the Participant Flow section.

DOS3w Dose Level 3B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/m2) 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.

DOS2W Dose Level 1A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 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.

DOS3W Dose Level 1B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 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.

DOS2W Dose Level 2A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 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.

DOS2W Dose Level 3A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 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.

DOS2W Dose Level 4A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 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.

DOS3W Dose Level 2B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 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.

DOS3W Dose Level 3B

Total

Age, Categorical

Sex: Female, Male

Denmark

Region of Enrollment

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/m2) will be given every 2nd week.

DOS2W 1A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

DOS2W 2A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

DOS2W 3A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.

DOS2W: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week.

DOS2W 4A

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week.

DOS3W 1B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week.

DOS3W 2B

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.

DOS3W: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week.

DOS3W 3B

Median Overall Survival

3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 30x2

DOS2w 1A

3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2

DOS2w 2A

6 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2

DOS 2w 3A

6 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2

DOS2w 4A

3 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2

DOS3w 1B

8 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2

DOS3w 2B

5 patients Docetaxel mg/m2 day 1: 60 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2

Spots Global Cancer Trial Database for dos3w dose level 3b