Phase 2
N=30
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Gastric Cancer · Stomach Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00857246 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Mar 2015
Primary outcome: Primary: Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab — 40 percentage of paticipants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); Irinotecan (Drug); Cisplatin (Drug); Surgery (Procedure); 5-FU (Drug); Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab |
40 | — |
| SECONDARY Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy |
— | — |
| SECONDARY Rate of Potentially Curative Surgery |
78 | — |
| SECONDARY Rate of "Down-staging" From Pre-operative Clinical Staging |
53 | — |
| SECONDARY Safety of the Induction Regimen |
13; 4; 3; 3; 2; 2 | — |
| SECONDARY Median Overall Survival (Induction Treatment and Curative Surgery) |
35.3 | — |
| SECONDARY Median Overall Survival (Adjuvant Therpary) |
39.5 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00857246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.