Efficacy of Cetuximab in Combination With Irinotecan and 5- FU/FA in Treatment of Metastatic Gastric Cancer

NCT ID: NCT01123811

Last Updated: 2010-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-05-31

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.

Detailed Description

Cetuximab will be analysed with biological markers

Conditions

Adenocarcinoma of Stomach or Esophagogastric Junction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab IF

Treatment with combination of Cetuximab and Irinotecan 5-FU

Group Type: EXPERIMENTAL

Cetuximab IF

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

na-folinat oncofolic

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AIO-Studien-gGmbH

OTHER

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Johannes Gutenberg University Mainz

Principal Investigators

M Moehler, Md Ph D

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg Univetsity

Locations

Städtische Kliniken Esslingen

Esslingen am Neckar, Baden-Wurttemberg, Germany

Klinikum Ludwigsburg, Medizinische Klinik I

Ludwigsburg, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm, Abt. Innere Medizin I

Ulm, Baden-Wurttemberg, Germany

Klinikum rechts der Isar der technischen Universität München, III. Medizinische Klinik: Hämatologie / Onkologie

München, Bavaria, Germany

Medizinische Hochschule Hannover, Abteilung Gastroenterologie, Hepatologie und Endokrinologie

Hanover, Lower Saxony, Germany

Universitätsklinkum Essen, Innere Klinik und Poliklinik - Tumorforschung

Essen, North Rhine-Westphalia, Germany

Kliniken Essen-Mitte / Evang. Huyssens-Stiftung, Klinik für Innere Medizin I und Internistische Onkologie / Hämatologie

Essen, North Rhine-Westphalia, Germany

Prosper-Hospital Recklinghausen, Medizinische Klinik I

Recklinghausen, North Rhine-Westphalia, Germany

Klinikum der Johannes Gutenberg-Universität, I. Medizinische Klinik u. Poliklinik

Mainz, Rhineland-Palatinate, Germany

Charité - Campus Benjamin Franklin, Medizinische Klinik I

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

GC-CIF-2005

Identifier Type: -

Identifier Source: org_study_id