Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started Jul 2005
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 7, 2015
November 1, 2015
6.2 years
March 4, 2009
March 2, 2015
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
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 Outcomes (6)
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
4 months from the beginning of the induction treatment
Rate of Potentially Curative Surgery
4 months from the beginning of the induction treatment
Rate of "Down-staging" From Pre-operative Clinical Staging
4 months from the beginning of the induction treatment
Safety of the Induction Regimen
4 months from the beginning of the induction
Median Overall Survival (Induction Treatment and Curative Surgery)
up to 5 years
- +1 more secondary outcomes
Study Arms (1)
Induction/ surgery/ chemoRT
EXPERIMENTAL1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Bristol-Myers Squibbcollaborator
- Eli Lilly and Companycollaborator
Study Sites (1)
NYU Cancer Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theresa Ryan, MD
- Organization
- Perlmutter Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Ryan, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2009
First Posted
March 6, 2009
Study Start
July 1, 2005
Primary Completion
September 1, 2011
Study Completion
October 1, 2015
Last Updated
December 7, 2015
Results First Posted
March 13, 2015
Record last verified: 2015-11