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Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer, Stomach Cancer

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Trial Information

Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation

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. The combination of
Irinotecan and Cisplatin has been shown to be synergistic and active against gastric
carcinoma. This trial therefore builds upon our 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
esophago-gastric 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.

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 EGFR status by 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

- 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

- The PT and PTT should be within the range of normal values

- Hepatic function: bilirubin not greater than 1.5 x ULN; AST not greater than 2.5 x

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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical response rate (RR) of an induction regimen consisting of Irinotecan, Cisplatin and Cetuximab

Outcome Time Frame:

4 months from the beginning of the induction regimen

Safety Issue:


Principal Investigator

Theresa Ryan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:

04-72 (H12637)



Start Date:

July 2005

Completion Date:

March 2014

Related Keywords:

  • Gastric Cancer
  • Stomach Cancer
  • stomach cancer
  • biologics
  • antibody
  • chemotherapy
  • chemoradiation
  • adjuvant therapy
  • neoadjuvant therapy
  • epidermal growth factor receptor
  • combination therapy
  • Stomach Neoplasms



NYU Cancer Center New York, New York  10016