Study of Cetuximab to Treat Gastric Cancer

Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00699881

Acronym

STAGE

Enrollment

Registered

2008-06-18

Start date

2008-05-31

Completion date

2009-10-31

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Time to Progression, Toxicity, Overall survival, Response rate, Quality of live

Brief summary

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Detailed description

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Interventions

DRUGcetuximab

cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ECOG performance scale ≤ 1 * At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) * Adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/L, neutrophil\>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion criteria

* Pregnant or lactating women * Concurrent cancer * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Neuropathy, brain, or leptomeningeal involvement * Uncontrolled significant comorbid conditions and previous radiotherapy

Design outcomes

Primary

Measure	Time frame
time to progression	every 8 weeks

Secondary

Measure	Time frame
toxicity	every 8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026