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

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

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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of Stomach or Esophagogastric Junction
• Intervention / Treatment: Drug: Cetuximab IF

Detailed Description

Cetuximab will be analysed with biological markers

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: na-folinat oncofolic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
objective response rate	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	1 month

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: AIO-Studien-gGmbH
• Investigators: Principal Investigator: M Moehler, Md Ph D, Johannes Gutenberg Univetsity

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): May 14, 2010
• Last Update Submitted That Met QC Criteria: May 12, 2010
• Last Verified: March 1, 2006

More Information

Terms related to this study

• Keywords: gastric cancer; adenocarcinoma; esophagogastric junction cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Adenocarcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: GC-CIF-2005