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

NCT ID: NCT00857246

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Gastric Cancer; Stomach Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction/ surgery/ chemoRT

1. 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

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

5-FU

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Interventions

Cetuximab

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

5-FU

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Other Intervention Names

Erbitux; CPT-11; Camptosar; Platinol-AQ; Fluorourocil

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

BMS #CA225112

Identifier Type: OTHER

Identifier Source: secondary_id

04-72 (H12637)

Identifier Type: -

Identifier Source: org_study_id