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A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer

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 safety of chemotherapy in advanced stomach cancers.

The combination of 5-fluorouracil plus cisplatin (FP) has been widely used for the
first-line treatment of advanced gastric cancer in many countries.

Randomized phase III trial investigating capecitabine plus cisplatin(XP) versus FP showed XP
is at least as good as FP with improved patients' preference.

A Phase II study of capecitabine plus oxaliplatin (XELOX) was conducted in our study group.
Among 52 patients enrolled, the RR was 63% with CR in 3 patients and median PFS was 6.5
months; median OS was not reached at the time of analysis. The grade 4 neutropenia was found
only in 1 patient and grade 3 or worse toxicities were rare. The RR achieved was comparable
to triplet combinations and tolerability was much better than cisplatin-based regimens.

The EGFR/ligand system seems to be involved in the regulation of gastric mucosa
proliferation and progression of gastric carcinomas. Elevated EGFR levels were found in
gastric carcinomas showing worse prognostic factors.

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,

- 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

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

November 2006

Completion Date:

September 2008

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • chemotherapy
  • cetuximab
  • capecitabine
  • oxaliplatin
  • Stomach Neoplasms