Study of Cetuximab to Treat Gastric Cancer

Gastric Cancer Clinical Trial

— STAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699881
• Other study ID #: EMR 62202- 806
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: December 21, 2009
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2008
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cetuximab
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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		every 8 weeks	No
Secondary	toxicity		every 8 weeks	Yes