Clinical trial NCT01123811: Efficacy of Cetuximab in Combination With Irinotecan and 5- FU/FA in Treatment of Metastatic Gastric Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of Stomach or Esophagogastric Junction
Keywords: adenocarcinoma
gastric cancer
esophagogastric junction cancer
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: AIO-Studien-gGmbH
First posted: 2010-05-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: objective response rate
timeFrame: 1 month
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1 month
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Städtische Kliniken Esslingen
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg, Medizinische Klinik I
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Abt. Innere Medizin I
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum rechts der Isar der technischen Universität München, III. Medizinische Klinik: Hämatologie / Onkologie
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Abteilung Gastroenterologie, Hepatologie und Endokrinologie
state: Niedersachsen
city: Essen
country: Germany
facility: Universitätsklinkum Essen, Innere Klinik und Poliklinik - Tumorforschung
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte / Evang. Huyssens-Stiftung, Klinik für Innere Medizin I und Internistische Onkologie / Hämatologie
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
facility: Prosper-Hospital Recklinghausen, Medizinische Klinik I
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität, I. Medizinische Klinik u. Poliklinik
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin, Medizinische Klinik I
Study officials:
affiliation: Johannes Gutenberg Univetsity
name: M Moehler, Md Ph D
role: PRINCIPAL_INVESTIGATOR
References: