Stomach Cancer
Conditions
Keywords
To determine maximal tolerated dose of DXO regimen
Brief summary
Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than other regimens and feasible in advanced gastric cancer. DXO regimen can be also easily administered on out-patient setting. However, so far, DXO combination has not been tried in advanced gastric cancer. The investigators will determine maximum tolerated dose of DXO regimen in this phase I study.
Interventions
DRUGDocetaxel, Capecitabine and Oxaliplatin
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma * Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel, capecitabine, or oxaliplatin as adjuvant chemotherapy should be excluded.) * Age 18 to 70 years old * Eastern Cooperative Oncology Group performance status 0\ 2 * Adequate bone marrow function: white blood cell counts \>4,000/µL, absolute neutrophil count \>2,000/µL, and platelets\>100,000/µL * Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance 60ml/min * Adequate hepatic function: bilirubin \< 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels \< 2.5 x UNL, and alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease) * Given written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
Exclusion criteria
* Contraindication to any drug contained in the chemotherapy regimen * Other tumor type than adenocarcinoma * Presence or history of central nervous system (CNS) metastasis * Gastric outlet or bowel obstruction * Evidence of serious gastrointestinal bleeding * Peripheral neuropathy \> grade 1 * History of significant neurologic or psychiatric disorders * History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential * Sexually active males and females (of childbearing potential) unwilling to practice conception during the study * Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in electrocardiogram) or myocardial infarction within the last 6 months * Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) * Serious metabolic disease such as severe non-compensated diabetes mellitus * Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease * Positive serology for the human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With DLTs | 2 years | 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DXP Arm Docetaxel, capecitabine and oxaliplatin | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | DXP Arm |
|---|---|
| Age, Customized | 50 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Korea, Republic of | 21 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 22 |
| serious Total, serious adverse events | 7 / 21 |
Outcome results
Primary
Number of Participants With DLTs
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
Time frame: 2 years
Population: All patients who were initially enrolled in dose escalation scheme.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DXO Arm | Number of Participants With DLTs | 3 participants |