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

Stage IV Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062374
• Other study ID #: NCI-2012-01438
• Secondary ID: 03-032NCI-5917CD
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: June 3, 2013
• Start date: June 2003

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. To evaluate the correlation of FDG-PET/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 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 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 every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction

• Tumors involving the GE junction must have the bulk of disease in the stomach

• Siewert's type II and III tumors involving the GE junction are eligible

• Tumors of the distal esophagus that extend less than 2 cm into the stomach are ineligible

• Locally advanced disease that is potentially curable by surgery

• Any T, N+, M0 or T3-T4, any N, M0 by staging CT scan and laparoscopy or endoscopic ultrasound

• No T1-T2, N0, M0 tumors

• No metastatic disease

• Any suspected sites of M1 disease must be proven to be M0

• Performance status - Karnofsky 60-100%

• Performance status - ECOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• Creatinine no greater than 1.5 mg/dL

• No history of active angina

• No New York Heart Association class III or IV heart disease

• No myocardial infarction within the past 6 months

• No history of significant ventricular arrhythmia requiring antiarrhythmic medication

• No history of clinically significant conduction system abnormality

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No concurrent serious infection

• No other uncontrolled medical illness that would preclude study participation

• No psychiatric illness that would preclude study compliance

• No clinically significant auditory impairment

• No pre-existing peripheral neuropathy grade 2 or greater

• No other active malignancy within the past 5 years except nonmelanoma skin cancer, nonmetastatic prostate cancer, or carcinoma in situ of the cervix

• Able to tolerate the proposed study surgical procedure and chemotherapy regimen

• No prior biologic therapy for this disease

• No prior chemotherapy for this disease

• No other concurrent chemotherapy

• No prior radiotherapy for this disease

• See Disease Characteristics

• No concurrent vitamins, antioxidants, or herbal preparations or supplements

• A single daily multivitamin tablet is allowed

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Stomach
• Stage II Gastric Cancer
• Stage III Gastric Cancer
• Stage IV Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• irinotecan hydrochloride
Given IV
• cisplatin
Given IV

Procedure:
• conventional surgery
Undergo radical subtotal or total gastrectomy with lymph node dissection
• positron emission tomography/computed tomography
Undergo FDG-PET/CT

Radiation:
• fludeoxyglucose F 18
Undergo FDG-PET/CT

Procedure:
• positron emission tomography/computed tomography
Undergo FLT-PET/CT

Other:
• fluorine F 18 fluorothymidine
Undergo FLT-PET/CT

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological response determined by a significant drop in FDG uptake correlates	Using a two sample t-test with 30 evaluable patients, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders.	Day 15	No