Study of XELOX With Cetuximab in Advanced Gastric Cancer

NCT00398398 | Completed Phase 2 Results

• 2 other identifiers: AMC0603EMR 62202-723,OXALI_L_01600
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastric Cancer

Keywords

gastric cancer; chemotherapy; cetuximab; capecitabine; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  6 months

Secondary Outcomes (3)

• Progression-free Survival

  1 year

• Overall Survival

  1 year

• Toxicity Profile

  1 years

Study Arms (1)

Capecitbine, oxaliplatin, cetuximab

EXPERIMENTAL

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

Interventions

Capecitabine, Oxaliplatin, Cetuximab DRUG

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.

Also known as: xeloda, oxalitin, Erbitux

Capecitbine, oxaliplatin, cetuximab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (3)

Asan Medical Center

Seoul, South Korea

Location

Korea Cancer Center Hospital

Seoul, South Korea

Location

Seoul Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Oxaliplatin; Cetuximab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 7, 2020
• Results First Posted: November 2, 2015

Record last verified: 2020-01

Locations

KR (3)