Chemotherapy for Patients With Cancer of the Stomach

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

June 5, 2015

Study Completion Date

December 17, 2015

Conditions
First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Interventions
DRUG

DOS2w Dose level 1A

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.

DRUG

DOS2w Dose level 2A

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.

DRUG

DOS2w Dose level 3A

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.

DRUG

DOS2w Dose level 4A

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.

DRUG

DOS3w Dose level 1B

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.

DRUG

DOS3w Dose level 2B

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.

DRUG

DOS3w Dose level 3B

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.

Trial Locations (1)

5000

Odense University Hospital, Odense

All Listed Sponsors
lead

Per Pfeiffer

OTHER

NCT01928524 - Chemotherapy for Patients With Cancer of the Stomach | Biotech Hunter | Biotech Hunter