Clinical trial NCT00398398: Study of XELOX With Cetuximab in Advanced Gastric Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
chemotherapy
cetuximab
capecitabine
oxaliplatin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Toxicity Profile
timeFrame: 1 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Samsung Medical Center
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: