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

This study has been completed.
Sponsor:
Collaborator:
AIO-Studien-gGmbH
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01123811
First received: May 7, 2010
Last updated: May 12, 2010
Last verified: March 2006
  Purpose

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 Intervention Phase
Adenocarcinoma of Stomach or Esophagogastric Junction
Drug: Cetuximab IF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • objective response rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Cetuximab will be analysed with biological markers

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123811

Locations
Germany
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
AIO-Studien-gGmbH
Investigators
Principal Investigator: M Moehler, Md Ph D Johannes Gutenberg Univetsity
  More Information

No publications provided

Responsible Party: M Moehler, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01123811     History of Changes
Other Study ID Numbers: GC-CIF-2005
Study First Received: May 7, 2010
Last Updated: May 12, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cetuximab
Irinotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014