Trial Outcomes & Findings for Chemotherapy for Patients With Cancer of the Stomach (NCT NCT01928524)
NCT ID: NCT01928524
Last Updated: 2021-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to 2 years after first administration of DOS
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
DOS2w 1A
3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 30x2
|
DOS2w 2A
3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
|
DOS 2w 3A
6 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
|
DOS2w 4A
6 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2
|
DOS3w 1B
3 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
|
DOS3w 2B
8 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
|
DOS3w 3B
5 patients Docetaxel mg/m2 day 1: 60 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
6
|
3
|
8
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
6
|
3
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy for Patients With Cancer of the Stomach
Baseline characteristics by cohort
| Measure |
DOS2W Dose Level 1A
n=3 Participants
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.
|
DOS3W Dose Level 1B
n=3 Participants
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.
|
DOS2W Dose Level 2A
n=3 Participants
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 3A
n=6 Participants
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 4A
n=6 Participants
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.
|
DOS3W Dose Level 2B
n=8 Participants
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 3B
n=5 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
8 participants
n=8 Participants
|
5 participants
n=8 Participants
|
34 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after first administration of DOSOutcome measures
| Measure |
DOS2W 1A
n=3 Participants
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 2A
n=3 Participants
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 3A
n=6 Participants
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 4A
n=6 Participants
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.
|
DOS3W 1B
n=3 Participants
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 2B
n=8 Participants
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 3B
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Median Overall Survival
|
4.3 Months
Interval 1.0 to 8.0
|
13.8 Months
Interval 7.0 to 16.0
|
14.6 Months
Interval 7.0 to 25.0
|
15.2 Months
Interval 6.0 to 26.0
|
8.3 Months
Interval 5.0 to 12.0
|
16.4 Months
Interval 8.0 to 24.0
|
7.8 Months
Interval 4.0 to 13.0
|
Adverse Events
DOS2w Dose Level 1A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
DOS2w Dose Level 2A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
DOS2w Dose Level 3A
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
DOS2w Dose Level 4A
Serious events: 2 serious events
Other events: 0 other events
Deaths: 3 deaths
DOS3w Dose Level 1B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
DOS3w Dose Level 2B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 6 deaths
DOS3w Dose Level 3B
Serious events: 2 serious events
Other events: 3 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
DOS2w Dose Level 1A
n=3 participants at risk
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 2A
n=3 participants at risk
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 3A
n=6 participants at risk
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 4A
n=6 participants at risk
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.
|
DOS3w Dose Level 1B
n=3 participants at risk
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 2B
n=8 participants at risk
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 3B
n=5 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
33.3%
2/6 • Number of events 2 • 18 weeks
|
33.3%
2/6 • Number of events 2 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
12.5%
1/8 • Number of events 1 • 18 weeks
|
40.0%
2/5 • Number of events 2 • 18 weeks
|
Other adverse events
| Measure |
DOS2w Dose Level 1A
n=3 participants at risk
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 2A
n=3 participants at risk
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 3A
n=6 participants at risk
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 4A
n=6 participants at risk
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.
|
DOS3w Dose Level 1B
n=3 participants at risk
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 2B
n=8 participants at risk
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 3B
n=5 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea grade 3-4
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
16.7%
1/6 • Number of events 1 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
0.00%
0/8 • 18 weeks
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Nausea grade 3-4
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
12.5%
1/8 • Number of events 1 • 18 weeks
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting grade 3-4
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
12.5%
1/8 • Number of events 1 • 18 weeks
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
|
General disorders
Fatigue grade 3-4
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
33.3%
2/6 • Number of events 2 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
0.00%
0/8 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
|
Nervous system disorders
Neuropathy grade 3-4
|
0.00%
0/3 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
16.7%
1/6 • Number of events 1 • 18 weeks
|
0.00%
0/6 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
0.00%
0/8 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place