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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Capecitabine and Oxaliplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel, Capecitabine and Oxaliplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Koo Kang, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | DXO Arm | Docetaxel, capecitabine and oxaliplatin Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DXP Arm | Docetaxel, capecitabine and oxaliplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All patients who were initially enrolled in dose escalation scheme. | Posted | Number | participants | 2 years |
|
6 months after completion of study treatment. If patients received another treatment, further evaluation was not done.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DXO Arm | Docetaxel, capecitabine and oxaliplatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | NCI_CTC_AE_v3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoon-Koo Kang | Asan Medical Center | +82-2-3010-3210 | ykkang@amc.seoul.kr |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 7 |
| 21 |
| 12 |
| 22 |
| Diarrhea | Gastrointestinal disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Asthenia | General disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Nail toxicity | Skin and subcutaneous tissue disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | NCI_CTC_AE_v3.0 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |