- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00857246
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
November 6, 2015 updated by: NYU Langone Health
Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer.
To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU).
The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma.
This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers.
The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10016
- NYU Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have signed an approved informed consent.
- must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
- Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
- Patients with Performance Status 0-2.
- Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.
- Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).
- The PT and PTT should be within the range of normal values
- Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.
Exclusion Criteria:
- Acute hepatitis or known HIV.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
- Prior therapy that affects or targets the EGF pathway.
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Induction/ surgery/ chemoRT
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days |
Other Names:
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
Time Frame: 4 months from the beginning of the induction regimen
|
Clinical response rate is defined as the percentage of patients who responded to the induction regimen.
The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage.
Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
|
4 months from the beginning of the induction regimen
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
Time Frame: 4 months from the beginning of the induction treatment
|
This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
|
4 months from the beginning of the induction treatment
|
Rate of Potentially Curative Surgery
Time Frame: 4 months from the beginning of the induction treatment
|
This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
|
4 months from the beginning of the induction treatment
|
Rate of "Down-staging" From Pre-operative Clinical Staging
Time Frame: 4 months from the beginning of the induction treatment
|
This is defined as the percentage of patients who had a reduction from T3/T4 disease.
|
4 months from the beginning of the induction treatment
|
Safety of the Induction Regimen
Time Frame: 4 months from the beginning of the induction
|
This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
|
4 months from the beginning of the induction
|
Median Overall Survival (Induction Treatment and Curative Surgery)
Time Frame: up to 5 years
|
This is the length of time from the start of treatment that half of the patients are still alive.
|
up to 5 years
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Median Overall Survival (Adjuvant Therpary)
Time Frame: up to 5 years
|
This is the length of time from the start of treatment that half of the patients are still alive.
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up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Theresa Ryan, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
March 4, 2009
First Submitted That Met QC Criteria
March 4, 2009
First Posted (Estimate)
March 6, 2009
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
November 6, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Topoisomerase I Inhibitors
- Irinotecan
- Cetuximab
Other Study ID Numbers
- 04-72 (H12637)
- BMS #CA225112 (Other Identifier: Bristol-Myers Squibb)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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