Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. Correlate the early-treatment F18-fluorodeoxyglucose positron emission tomography (FDG-PET/CT) response with histologic response and patient outcome, in terms of overall and progression-free survival, in patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant irinotecan and cisplatin followed by surgical resection.
2. Determine the efficacy and safety of this regimen in these patients.
3. Evaluate the biology of locally advanced gastric cancer and response to chemotherapy by DNA microarray and histopathology in these patients.
4. Determine, preliminarily, biodistribution, dosimetry, and potential clinical usefulness of F18-fluorothymidine PET (FLT-PET/CT) in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy for this disease

Chemotherapy

• No prior chemotherapy for this disease
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for this disease

Surgery

• See Disease Characteristics

Other

• No concurrent vitamins, antioxidants, or herbal preparations or supplements
  • A single daily multivitamin tablet is allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

  OR

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• 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

Other

• 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

Expected Enrollment

A total of 40 patients will be accrued for this study within 10 months.

Outcomes

Correlation of fluorodeoxyglucose positron emission tomography imaging with histologic response, overall survival, and progression-free survival

Efficacy and safety
Response to chemotherapy as assessed by DNA microarray and histopathology
Biodistribution, dosimetry, and potential clinical usefulness of F18-fluorothymidine PET

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.

Shah MA, Yeung H, Coit D, et al.: A phase II study of preoperative chemotherapy with irinotecan(CPT) and cisplatin(CIS) for gastric cancer (NCI 5917): FDG-PET/CT predicts patient outcome. [Abstract] J Clin Oncol 25 (Suppl 18): A-4502, 2007.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Manish Shah, MD, Protocol chair		Ph: 212-639-3113; 800-525-2225

Registry Information
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
Trial Start Date		2003-06-05
Trial Completion Date		2011-06-28
Registered in ClinicalTrials.gov		NCT00062374
Date Submitted to PDQ		2003-05-06
Information Last Verified		2006-09-29
NCI Grant/Contract Number		CM17105, CA08748

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