Clinical trial NCT00062374
Conditions: Gastric Adenocarcinoma Stage II Gastric Cancer Stage III Gastric Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-06-01; Completion date: 2011-06-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Neoadjuvant chemotherapy: Patients receive cisplatin 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.
Interventions: intervention 1: Cisplatin intervention 2: Computed Tomography intervention 3: Fludeoxyglucose F-18 intervention 4: Fluorothymidine F-18 intervention 5: Irinotecan Hydrochloride intervention 6: Positron Emission Tomography intervention 7: Therapeutic Conventional Surgery
Intervention descriptions: intervention 1: Given IV intervention 2: Undergo FDG and FLT PET/CT intervention 3: Undergo FDG-PET/CT intervention 4: Undergo FLT-PET/CT intervention 5: Given IV intervention 6: Undergo FDG and FLT PET/CT intervention 7: Undergo radical subtotal or total gastrectomy with lymph node dissection

Protocol documents: