Study of XELOX With Cetuximab in Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Capecitabine; Cetuximab; Oxaliplatin

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.