Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Stomach Stage II Gastric Cancer Stage III Gastric Cancer Stage IV Gastric Cancer |
Drug: irinotecan hydrochloride Drug: cisplatin Procedure: conventional surgery Procedure: positron emission tomography/computed tomography Radiation: fludeoxyglucose F 18 Other: fluorine F 18 fluorothymidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Histological response determined by a significant drop in FDG uptake correlates [ Time Frame: Day 15 ] [ Designated as safety issue: No ]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.
| Enrollment: | 40 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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. |
Drug: irinotecan hydrochloride
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Procedure: conventional surgery
Undergo radical subtotal or total gastrectomy with lymph node dissection
Other Name: surgery, conventional
Procedure: positron emission tomography/computed tomography
Undergo FDG-PET/CT
Radiation: fludeoxyglucose F 18
Undergo FDG-PET/CT
Other Names:
Procedure: positron emission tomography/computed tomography
Undergo FLT-PET/CT
Other: fluorine F 18 fluorothymidine
Undergo FLT-PET/CT
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center at Suffolk | |
| Commack, New York, United States, 11725 | |
| Principal Investigator: | Manisha Shah | Memorial Sloan-Kettering Cancer Center at Suffolk |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062374 History of Changes |
| Other Study ID Numbers: | NCI-2012-01438, 03-032, CDR0000304738 |
| Study First Received: | June 5, 2003 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Irinotecan Cisplatin Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013