Trial Outcomes & Findings for Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer (NCT NCT00446290)

Last Updated: 2020-01-18

Results Overview

Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

22 participants

Primary outcome timeframe

2 years

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	DXO Arm Docetaxel, capecitabine and oxaliplatin Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2) 1. 45 800 100 2. 60 800 100 3. 60 1,000 100 4. 60 800 130 5. 60 1,000 130
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DXP Arm n=21 Participants Docetaxel, capecitabine and oxaliplatin
Age, Customized	50 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All patients who were initially enrolled in dose escalation scheme.

Outcome measures

Outcome measures
Measure	DXO Arm n=15 Participants Docetaxel, capecitabine and oxaliplatin
Number of Participants With DLTs	3 participants

Adverse Events

DXO Arm

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DXO Arm n=22 participants at risk；n=21 participants at risk Docetaxel, capecitabine and oxaliplatin
Infections and infestations Febrile neutropenia	28.6% 6/21 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Gastrointestinal disorders Diarrhea	9.5% 2/21 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.

Other adverse events

Other adverse events
Measure	DXO Arm n=22 participants at risk；n=21 participants at risk Docetaxel, capecitabine and oxaliplatin
Blood and lymphatic system disorders Anemia	50.0% 11/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Blood and lymphatic system disorders Leukopenia	45.5% 10/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Blood and lymphatic system disorders Neutropenia	50.0% 11/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Blood and lymphatic system disorders Thrombocytopenia	36.4% 8/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Infections and infestations Febrile neutropenia	13.6% 3/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
General disorders Asthenia	54.5% 12/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Gastrointestinal disorders Nausea	45.5% 10/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Gastrointestinal disorders Vomiting	22.7% 5/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Gastrointestinal disorders Stomatitis	31.8% 7/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Gastrointestinal disorders Diarrhea	36.4% 8/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Skin and subcutaneous tissue disorders Nail toxicity	40.9% 9/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Nervous system disorders Neuropathy	36.4% 8/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
Skin and subcutaneous tissue disorders Hand-foot syndrome	36.4% 8/22 • 6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place