Clinical trial · Interventional
Study of XELOX With Cetuximab in Advanced Gastric Cancer
A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
NCT00398398CI-TRIAL-00042613completedPhase 2Results 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)
The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in advanced gastric cancer, which is the investigators study rationale.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Oxaliplatin, Cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitbine, oxaliplatin, cetuximab
- description
- Capecitbine, oxaliplatin and cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
- interventionNames
- Drug: Capecitabine, Oxaliplatin, Cetuximab
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 6 months
- description
- Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Having given signed written informed consent * Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction. * Patients must have unresectable metastatic disease or recurrent disease after curative surgical resection with uni-dimensionally measurable disease according to RECIST (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination * Age 18 to 70 years old * Estimated life expectancy of more than 3 months * ECOG performance status \< 2 (See Appendix E) * Adequate bone marrow function (WBC\>3,000/µL, ANC\>1,500/µL, and platelets\>100,000/µL, Hb\>8g/dl) * Adequate kidney function (creatinine\<1.5 mg/dL) * Adequate liver function \[bilirubin\< 2.0 mg/dL, transaminases levels\<3 times the Upper Normal Value (5 times for patients with liver metastasis)\] * Prothrombin time not less than 50% of Lower Normal Value * No prior chemotherapy * No prior radiation therapy * Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study. * Women of childbearing potential must have a negative serum HCG pregnancy test on admission. Men and women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment. Exclusion Criteria: * Past or concurrent history of neoplasm other than gastric adenocarcinoma within the last five years, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri. * Central nervous system (CNS) metastases. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start * Gastric outlet obstruction, intestinal obstruction and obvious peritoneal seeding. * Evidence of serious gastrointestinal bleeding. * The patient has bony lesions as the sole evaluable disease. * Pregnant or lactating women, women of childbearing potential not employing adequate contraception. * Patients with sensory neuropathy (grade\> 1 according to NCI CTCAE v. 3.0). * Hypersensitivity to any of the study drugs or ingredients. * Other serious illness or medical conditions that would not allow study participation in the best interest of the patient as decided by the investigator. * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry. * History of significant neurologic or psychiatric disorders including dementia or seizures. * Active uncontrolled infection. * Pre-existing clinically significant diarrhea. * Unstable diabetes mellitus. * Severe hypercalcemia of \> 12 mg/dL and uncontrolled with bisphosphonates. * Active disseminated intravascular coagulation. * Concurrent treatment with corticosteroids (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or nausea, or unless chronic treatment (initiated \> 6 months prior to study entry) at low dose (\<20 mg methyl prednisolone or equivalent). * Concomitant or administration of any other experimental drug under investigation within 4 weeks before the study. * Concomitant or previous hormonal therapy, or immunotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.