Overview

This trial is active, not recruiting.

Conditions gastric cancer, stomach cancer
Treatment cetuximab/ irinotecan/ cisplatin
Phase phase 2
Sponsor New York University School of Medicine
Collaborator Bristol-Myers Squibb
Start date July 2005
End date September 2011
Trial size 30 participants
Trial identifier NCT00857246, 04-72 (H12637), BMS #CA225112

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cetuximab/ irinotecan/ cisplatin Cetuximab: Erbitux
Induction treatment (3 weeks/cycle x 4 cycles): Day 1, 8: Cisplatin 25 mg/m^2, Irinotecan 75 mg/m^2. Day 1, 8, 15: Cetuximab 400 mg/m^2 initial dose, then 250 mg/m^2 weekly. Surgery (3-4 weeks after induction treatment). Chemoradiation treatment (4-6 weeks after surgery): weeks 1-19: Cetuximab 250 mg/m^2 weekly on day 1 of every week; week 1: 5-FU 425 mg/m^2/day x 5 days + Leucovorin (LV) 20 mg/m^2/day x 5days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU 400 mg/m^2 + LV 20 mg/m^2 each day on days 1-4; week 9: 5-FU 400 mg/m^2 + LV 20 mg/m^2 each day on days 1-3; week 14: 5-FU 425 mg/m^2/day x 5 days + Leucovorin (LV) 20 mg/m^2/day x 5days; week 19: 5-FU 425 mg/m^2/day x 5 days + Leucovorin (LV) 20 mg/m^2/day x 5days.

Primary Outcomes

Measure
clinical response rate (RR) of an induction regimen consisting of Irinotecan, Cisplatin and Cetuximab
time frame: 4 months from the beginning of the induction regimen

Secondary Outcomes

Measure
rate of clearance of nodal involvement; rate of potentially curative surgery among patients who have received the induction therapy; rate of "down-staging" from pre-operative clinical staging
time frame: up to 1 year from the beginning of the induction treatment
safety of the regimen
time frame: 1 year after the start of first treatment and every year afterwards
overall survival
time frame: every 4 months for the 1st year, every 6 months for the 2nd and 3rd year, every 12 months thereafter for a total 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 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; 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).

Additional Information

Official title Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
Principal investigator Theresa Ryan, MD
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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by New York University School of Medicine.