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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062374
  Purpose

RATIONALE: 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.

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.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: fludeoxyglucose F 18
Drug: irinotecan hydrochloride
Procedure: computed tomography
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: positron emission tomography
Phase II

MedlinePlus related topics:   Cancer    Stomach Cancer   

Drug Information available for:   Cisplatin    Irinotecan    Irinotecan hydrochloride    Fluorodeoxyglucose F18   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of fluorodeoxyglucose positron emission tomography imaging with histologic response, overall survival, and progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy and safety [ Designated as safety issue: Yes ]
  • Response to chemotherapy as assessed by DNA microarray and histopathology [ Designated as safety issue: No ]
  • Biodistribution, dosimetry, and potential clinical usefulness of F18-fluorothymidine PET [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   June 2003

Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the efficacy and safety of this regimen in these patients.
  • Evaluate the biology of locally advanced gastric cancer and response to chemotherapy by DNA microarray and histopathology in these patients.
  • Determine, preliminarily, biodistribution, dosimetry, and potential clinical usefulness of F18-fluorothymidine PET (FLT-PET/CT) in patients treated with these regimens.

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.

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062374

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia    
      Philadelphia, Pennsylvania, United States, 19111-2497

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Manish A. Shah, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000304738, MSKCC-03032, NCI-5917
First Received:   June 5, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00062374
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach  
stage II gastric cancer  
stage III gastric cancer  
stage IV gastric cancer  

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms
Irinotecan
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Camptothecin

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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