Efficacy of Cetuximab in Combination With Irinotecan and 5- FU/FA in Treatment of Metastatic Gastric Cancer (GC-CIF-2005)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01123811
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Information provided by:
Johannes Gutenberg University Mainz

Brief Summary:
Based on the current promising results with irinotecan and cetuximab in patients with recurrent metastatic colorectal cancer, and the excellent results of Irinotecan and 5-FU in gastric cancer , the present clinical study to evaluate the overall response rate, the time to progression and the overall survival of the combined treatment of cetuximab and irinotecan and 5-FU in patients with esophagogastric cancer is urgently needed.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Stomach or Esophagogastric Junction Drug: Cetuximab IF Phase 2

Detailed Description:
Cetuximab will be analysed with biological markers

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomized Phase II Trial of Cetuximab in Combination With Irinotecan and 5-FU/FA for Patients With Metastatic Gastric Cancer
Study Start Date : May 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cetuximab IF
Treatment with combination of Cetuximab and Irinotecan 5-FU
Drug: Cetuximab IF
Cetuximab loading dose 400 mg/m² weekly dose 250 mg/m² Irinotecan 80 mg/m2 i.v. over 2 hours day 1, 8, 15, 22, 29, 36 Folinic acid 200 mg/m2 over 24 hours day 1, 8, 15, 22, 29, 36 FA will be given as sodium folinate 5-FU 1500 mg/m2 continuous infusion over 24 hours day 1, 8, 15, 22, 29, 36
Other Name: na-folinat oncofolic

Primary Outcome Measures :
  1. objective response rate [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 seizures;
  • 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 treatment;
    • Known drug abuse/alcohol abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01123811

Städtische Kliniken Esslingen
Esslingen, Baden-Württemberg, Germany, 73730
Klinikum Ludwigsburg, Medizinische Klinik I
Ludwigsburg, Baden-Württemberg, Germany, 71640
Universitätsklinikum Ulm, Abt. Innere Medizin I
Ulm, Baden-Württemberg, Germany, 89070
Klinikum rechts der Isar der technischen Universität München, III. Medizinische Klinik: Hämatologie / Onkologie
München, Bayern, Germany, 81675
Medizinische Hochschule Hannover, Abteilung Gastroenterologie, Hepatologie und Endokrinologie
Hannover, Niedersachsen, Germany, 30623
Universitätsklinkum Essen, Innere Klinik und Poliklinik - Tumorforschung
Essen, Nordrhein-Westfalen, Germany, 45122
Kliniken Essen-Mitte / Evang. Huyssens-Stiftung, Klinik für Innere Medizin I und Internistische Onkologie / Hämatologie
Essen, Nordrhein-Westfalen, Germany, 45136
Prosper-Hospital Recklinghausen, Medizinische Klinik I
Recklinghausen, Nordrhein-Westfalen, Germany, 45659
Klinikum der Johannes Gutenberg-Universität, I. Medizinische Klinik u. Poliklinik
Mainz, Rheinland-Pfalz, Germany, 55101
Charité - Campus Benjamin Franklin, Medizinische Klinik I
Berlin, Germany, 12200
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: M Moehler, Md Ph D Johannes Gutenberg Univetsity

Responsible Party: M Moehler, Johannes Gutenberg University Mainz Identifier: NCT01123811     History of Changes
Other Study ID Numbers: GC-CIF-2005
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: May 14, 2010
Last Verified: March 2006

Keywords provided by Johannes Gutenberg University Mainz:
gastric cancer
esophagogastric junction cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action