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
18 Years
N/A
Both
Adenocarcinoma of the Stomach, Stage II Gastric Cancer, Stage III Gastric Cancer, Stage IV Gastric Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Histological response determined by a significant drop in FDG uptake correlates
Outcome Description:
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.
Outcome Time Frame:
Day 15
Safety Issue:
No
Principal Investigator
Manisha Shah
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01438
NCT ID:
NCT00062374
Start Date:
June 2003
Completion Date:
Related Keywords:
- Adenocarcinoma of the Stomach
- Stage II Gastric Cancer
- Stage III Gastric Cancer
- Stage IV Gastric Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
