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Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

Primary Purpose

Gastric Cancer, Stomach Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Irinotecan
Cisplatin
Surgery
5-FU
Radiation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring stomach cancer, biologics, antibody, chemotherapy, chemoradiation, adjuvant therapy, neoadjuvant therapy, epidermal growth factor receptor, combination therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • NYU Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction/ surgery/ chemoRT

Arm Description

Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. Surgery (starts 3-4 weeks after induction treatment). 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
Rate of Potentially Curative Surgery
This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
Rate of "Down-staging" From Pre-operative Clinical Staging
This is defined as the percentage of patients who had a reduction from T3/T4 disease.
Safety of the Induction Regimen
This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
Median Overall Survival (Induction Treatment and Curative Surgery)
This is the length of time from the start of treatment that half of the patients are still alive.
Median Overall Survival (Adjuvant Therpary)
This is the length of time from the start of treatment that half of the patients are still alive.

Full Information

First Posted
March 4, 2009
Last Updated
November 6, 2015
Sponsor
NYU Langone Health
Collaborators
Bristol-Myers Squibb, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00857246
Brief Title
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Official Title
Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Bristol-Myers Squibb, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Stomach Cancer
Keywords
stomach cancer, biologics, antibody, chemotherapy, chemoradiation, adjuvant therapy, neoadjuvant therapy, epidermal growth factor receptor, combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction/ surgery/ chemoRT
Arm Type
Experimental
Arm Description
Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. Surgery (starts 3-4 weeks after induction treatment). 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
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11, Camptosar
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol-AQ
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorourocil
Intervention Type
Radiation
Intervention Name(s)
Radiation
Primary Outcome Measure Information:
Title
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
Description
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.
Time Frame
4 months from the beginning of the induction regimen
Secondary Outcome Measure Information:
Title
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
Description
This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
Time Frame
4 months from the beginning of the induction treatment
Title
Rate of Potentially Curative Surgery
Description
This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
Time Frame
4 months from the beginning of the induction treatment
Title
Rate of "Down-staging" From Pre-operative Clinical Staging
Description
This is defined as the percentage of patients who had a reduction from T3/T4 disease.
Time Frame
4 months from the beginning of the induction treatment
Title
Safety of the Induction Regimen
Description
This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
Time Frame
4 months from the beginning of the induction
Title
Median Overall Survival (Induction Treatment and Curative Surgery)
Description
This is the length of time from the start of treatment that half of the patients are still alive.
Time Frame
up to 5 years
Title
Median Overall Survival (Adjuvant Therpary)
Description
This is the length of time from the start of treatment that half of the patients are still alive.
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Ryan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

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