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Study of XELOX With Cetuximab in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398398
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : November 2, 2015
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

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, which is the investigators study rationale.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine, Oxaliplatin, Cetuximab Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
Study Start Date : November 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Capecitbine, oxaliplatin, cetuximab
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.
Drug: Capecitabine, Oxaliplatin, Cetuximab
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.
Other Name: xeloda, oxalitin, Erbitux

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]
    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 Outcome Measures :
  1. Progression-free Survival [ Time Frame: 1 year ]
  2. Overall Survival [ Time Frame: 1 year ]
  3. Toxicity Profile [ Time Frame: 1 years ]
    Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398398

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Seoul Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Yoon-Koo Kang, MD, PhD Asan Medical Center

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Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT00398398     History of Changes
Other Study ID Numbers: AMC-ONCGI-0603
EMR 62202-723,OXALI_L_01600
First Posted: November 10, 2006    Key Record Dates
Results First Posted: November 2, 2015
Last Update Posted: August 21, 2017
Last Verified: July 2017
Keywords provided by Yoon-Koo Kang, Asan Medical Center:
gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological