NCT00062374

Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the correlation of fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) imaging early in the preoperative treatment program of locally advanced gastric cancer with histologic response assessment and patient outcome, defined as overall and progression-free survival. SECONDARY OBJECTIVES: I. To evaluate the efficacy and safety of preoperative chemotherapy with irinotecan and cisplatin in the treatment of locally advanced gastric cancer. II. To examine the biology of locally advanced gastric cancer and the response to chemotherapy by DNA microarray technology and by histopathology. III. To obtain preliminary data on biodistribution, dosimetry and explore the potential clinical usefulness of fluorodeoxythymidine (FLT) PET in patients with locally advanced gastric cancer undergoing a novel combination neoadjuvant chemotherapy. OUTLINE: This is an open-label, nonrandomized, multicenter study. Neoadjuvant chemotherapy: Patients receive cisplatin intravenously (IV) over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. Patients undergo fluorodeoxyglucose FDG-PET/CT at baseline. Some patients undergo additional FDG-PET/CT scans in weeks 3 and 6. Approximately 5 patients undergo fluorothymidine FLT-PET/CT at baseline, during week 3, and/or before surgical resection. Patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Conditions

• Gastric Adenocarcinoma
• Stage II Gastric Cancer
• Stage III Gastric Cancer
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
PROCEDURE	Computed Tomography	Undergo FDG and FLT PET/CT
RADIATION	Fludeoxyglucose F-18	Undergo FDG-PET/CT
OTHER	Fluorothymidine F-18	Undergo FLT-PET/CT
DRUG	Irinotecan Hydrochloride	Given IV
PROCEDURE	Positron Emission Tomography	Undergo FDG and FLT PET/CT
PROCEDURE	Therapeutic Conventional Surgery	Undergo radical subtotal or total gastrectomy with lymph node dissection

Timeline

• Start date: 2003-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2003-06-06
• Last updated: 2017-07-06
• Results posted: 2017-07-06

Locations

1 site across 1 country: United States