A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine, Oxaliplatin, Cetuximab
- Conditions
- Gastric Cancer
- Sponsor
- Asan Medical Center
- Enrollment
- 44
- Locations
- 3
- Primary Endpoint
- Overall Response Rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Yoon-Koo Kang
Professor
Asan Medical Center
Eligibility 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
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.
Arms & Interventions
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.
Intervention: Capecitabine, Oxaliplatin, Cetuximab
Outcomes
Primary Outcomes
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 Outcomes
- Progression-free Survival(1 year)
- Overall Survival(1 year)
- Toxicity Profile(1 years)