Study of XELOX With Cetuximab in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Capecitabine, Oxaliplatin, Cetuximab
Intervention description: Xelox(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.
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: gastric cancer; chemotherapy; cetuximab; capecitabine; oxaliplatin

Summary:

      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.
    

Eligibility criteria:

        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.