Status:
COMPLETED
Study of XELOX With Cetuximab in Advanced Gastric Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Detailed Description
There is presently no chemotherapy regimen considered to be the global standard of care for patients with AGC, and there is still a need for new agents and/or regimens to improve the efficacy and safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00398398
Start Date
November 1 2006
End Date
September 1 2008
Last Update
January 7 2020
Active Locations (3)
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1
Asan Medical Center
Seoul, South Korea
2
Korea Cancer Center Hospital
Seoul, South Korea
3
Seoul Samsung Medical Center
Seoul, South Korea