- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398398
Study of XELOX With Cetuximab in Advanced Gastric Cancer
A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Korea Cancer Center Hospital
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Seoul, Korea, Republic of
- Seoul Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 1 year
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1 year
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Progression-free Survival
Time Frame: 1 year
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1 year
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Toxicity Profile
Time Frame: 1 years
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Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab
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1 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Capecitabine
- Oxaliplatin
- Cetuximab
Other Study ID Numbers
- AMC0603
- EMR 62202-723,OXALI_L_01600
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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