Adenocarcinoma of Stomach or Esophagogastric JunctionPhase 2GC-CIF-2005NCT01123811
Efficacy of Cetuximab in Combination With Irinotecan and 5- FU/FA in Treatment of Metastatic Gastric Cancer
A Phase 2 study testing Cetuximab IF in people with Adenocarcinoma of Stomach or Esophagogastric Junction, run by Johannes Gutenberg University Mainz at 10 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Stomach or Esophagogastric Junction
- What is being tested?
- Cetuximab IF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesGermany
- Study dates
- May 2006to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Charité - Campus Benjamin Franklin, Medizinische Klinik I
Berlin, State of Berlin, 12200
Universitätsklinkum Essen, Innere Klinik und Poliklinik - Tumorforschung
Essen, North Rhine-Westphalia, 45122
Kliniken Essen-Mitte / Evang. Huyssens-Stiftung, Klinik für Innere Medizin I und Internistische Onkologie / Hämatologie
Essen, North Rhine-Westphalia, 45136
Städtische Kliniken Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73730
Medizinische Hochschule Hannover, Abteilung Gastroenterologie, Hepatologie und Endokrinologie
Hanover, Lower Saxony, 30623
Klinikum Ludwigsburg, Medizinische Klinik I
Ludwigsburg, Baden-Wurttemberg, 71640
Klinikum der Johannes Gutenberg-Universität, I. Medizinische Klinik u. Poliklinik
Mainz, Rhineland-Palatinate, 55101
Klinikum rechts der Isar der technischen Universität München, III. Medizinische Klinik: Hämatologie / Onkologie
München, Bavaria, 81675
Prosper-Hospital Recklinghausen, Medizinische Klinik I
Recklinghausen, North Rhine-Westphalia, 45659
Universitätsklinikum Ulm, Abt. Innere Medizin I
Ulm, Baden-Wurttemberg, 89070
About this study
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
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.
Read the detailed description
Cetuximab will be analysed with biological markers
- Being tested
- Cetuximab IF
- Keywords
- adenocarcinoma, gastric cancer, esophagogastric junction cancer
- Medical subject headings
- Adenocarcinoma, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab IFDrug
Also called na-folinat oncofolic
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
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab IF | Experimental | Treatment with combination of Cetuximab and Irinotecan 5-FU Receives: Drug: Cetuximab IF |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Measured: 1 month
Secondary outcomes (1)
Progression-free survival
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Stomach or Esophagogastric JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- AIO-Studien-gGmbH
- Investigators
- M Moehler, Md Ph D, Principal investigator, Johannes Gutenberg Univetsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123811
- Sponsor's protocol ID
- GC-CIF-2005
- Acronym
- GC-CIF-2005
- Status last verified
- Mar 2006
- First submitted
- 7 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01123811
- Acronym / sponsor ID
- GC-CIF-2005 / GC-CIF-2005
- Keywords
- adenocarcinoma, gastric cancer, esophagogastric junction cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- AIO-Studien-gGmbH
- Study start
- May 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab IF | Experimental | Drug: Cetuximab IFTreatment with combination of Cetuximab and Irinotecan 5-FU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab IFAlso: na-folinat oncofolicCetuximab 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 | Drug | Cetuximab IF |
Primary outcome
objective response rate
Time frame: 1 month
1 secondary outcome
Progression-free survival
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Moehler, Md Ph D principal investigator
Johannes Gutenberg Univetsity
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab IF in people with Adenocarcinoma of Stomach or Esophagogastric Junction, run by Johannes Gutenberg University Mainz at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010.