Clinical trial · Interventional
Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer
A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer
NCT00446290CI-TRIAL-00042845completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Capecitabine and Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel, Capecitabine and Oxaliplatin
- interventionNames
- Drug: Docetaxel, Capecitabine and Oxaliplatin
Primary outcomes (1)
- measure
- Number of Participants With DLTs
- timeFrame
- 2 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.