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

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Completed

CT.gov ID

NCT01123811

Collaborator

AIO-Studien-gGmbH (Other)

Enrollment

Locations

Arm

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2006

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

objective response rate [1 month]

Secondary Outcome Measures

Progression-free survival [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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