Know Cancer

forgot password

An Open-label, Non-randomized Phase II Trial of Cetuximab in Combination With Irinotecan and 5-FU/FA for Patients With Metastatic Gastric Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Adenocarcinoma of Stomach or Esophagogastric Junction

Thank you

Trial Information

An Open-label, Non-randomized Phase II Trial of Cetuximab in Combination With Irinotecan and 5-FU/FA for Patients With Metastatic Gastric Cancer

Cetuximab will be analysed with biological markers

Inclusion Criteria:

Signed and dated informed consent before the start of specific protocol procedures;

- Histologically proven gastric adenocarcinoma including adenocarcinoma of the
esophagogastric junction or Barrett carcinoma (adenocarcinoma of lower oesophagus);

- Measurable metastatic disease according to the RECIST criteria. If locally recurrent
disease, it must be associated with at least one measurable lymph node (> 20 mm by CT
scan or > 10 mm with spiral CT);

- Age: 18-75 years;

- ECOG Performance Status 0-2

- Life expectancy > 12 weeks;

- Adequate hematological, hepatic and renal functions: ANC

≥ 1.5 × 109/L, platelets ≥ 100 × 109/L; hemoglobin ≥ 10g/dl; creatinine ≤ 2 x UNL;
total bilirubin ≤ 3 x UNL, ASAT (SGOT) and ALAT (SGPT) ≤ 3 × UNL; in case of liver
metastases: total bilirubin ≤ 5 x UNL, ASAT (SGOT) and ALAT (SGPT) ≤ 5 × UNL;

- At least 4 weeks from surgery;

- Recovery from side effects of any prior therapy;

- Able to comply with scheduled assessments and with management of toxicity.

- If of childbearing potential, willingness to use effective contraceptive method for
the study duration and 2 months post-dosing.

Exclusion Criteria:

- Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second
cancer except in patients with squamous or basal cell carcinoma of the skin or
carcinoma in situ of the cervix which has been effectively treated. Patients
curatively treated and disease free for at least 5 years will be discussed with the
sponsor before inclusion;

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol;

- Any prior palliative chemotherapy, adjuvant (and/or neoadjuvant) chemotherapy or
radiotherapy ;

- Concurrent treatment with any other anti-cancer therapy;

- Patients with known brain or leptomeningeal metastasis;

- Hypercalcemia not controlled by bisphosphonates;

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection (> hemicolectomy or extensive small intestine resection
with chronic diarrhea), Crohn's disease, ulcerative colitis;

- Other serious illness or medical conditions:

- Unstable cardiac disease despite treatment, myocardial infarction within 6 months
prior to study entry; congestive heart failure NYHA grade 3 and 4;

- Current history of chronic diarrhea;

- History of significant neurologic or psychiatric disorders including dementia or

- Active uncontrolled infection;

- Active disseminated intravascular coagulation;

- Other serious underlying medical conditions which could impair the ability of the
patient to participate in the study;

- Known deficit in DPD

- Contraindications to the use of atropine;

- Concomitant or within a 4-week period administration of any other experimental
drug under investigation;

- Pregnant or lactating women;

- Previous exposure to monoclonal antibodies, signal transduction inhibitors or
EGFR pathway targeting therapy;

- Known allergic/hypersensitivity reaction to any of the components of the

- Known drug abuse/alcohol abuse.

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

M Moehler, Md Ph D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg Univetsity


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

May 2006

Completion Date:

May 2010

Related Keywords:

  • Adenocarcinoma of Stomach or Esophagogastric Junction
  • adenocarcinoma
  • gastric cancer
  • esophagogastric junction cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms