Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Stomach Cancer |
Drug: Cetuximab/ Irinotecan/ Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- safety of the regimen [ Time Frame: 1 year after the start of first treatment and every year afterwards ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | March 2014 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Induction chemo/ surgery/ chemoRT |
Drug: Cetuximab/ Irinotecan/ Cisplatin
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. Other Names:
|
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. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| United States, New York | |
| NYU Cancer Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Theresa Ryan, MD | New York University School of Medicine |
More Information
No publications provided
| Responsible Party: | Theresa Ryan, MD, NYU Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00857246 History of Changes |
| Other Study ID Numbers: | 04-72 (H12637), BMS #CA225112 |
| Study First Received: | March 4, 2009 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
stomach cancer biologics antibody chemotherapy chemoradiation |
adjuvant therapy neoadjuvant therapy epidermal growth factor receptor combination therapy |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Adjuvants, Immunologic Irinotecan Cetuximab Cisplatin Camptothecin |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013