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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

time to progression

Outcome Time Frame:

every 8 weeks

Safety Issue:

No

Principal Investigator

Jin Li, PhD, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

EMR 62202- 806

NCT ID:

NCT00699881

Start Date:

May 2008

Completion Date:

October 2009

Related Keywords:

  • Gastric Cancer
  • Time to Progression
  • Toxicity
  • Overall survival
  • Response rate
  • Quality of live
  • Stomach Neoplasms

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