Study of XELOX With Cetuximab in Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00398398
First received: November 9, 2006
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: Capecitabine, Oxaliplatin, Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
    Each cycle of chemotherapy according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCICTCAE] version 3.0


Enrollment: 44
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398398

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

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00398398     History of Changes
Other Study ID Numbers: AMC-ONCGI-0603, EMR 62202-723,OXALI_L_01600
Study First Received: November 9, 2006
Last Updated: January 16, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
gastric cancer
chemotherapy
cetuximab
capecitabine
oxaliplatin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014