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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062374
First received: June 5, 2003
Last updated: June 3, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
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:
  • 18FDG
  • FDG
Procedure: positron emission tomography/computed tomography
Undergo FLT-PET/CT
Other: fluorine F 18 fluorothymidine
Undergo FLT-PET/CT
Other Names:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorothymidine
  • fluorothymidine F-18

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 10065
Sponsors and Collaborators
Investigators
Principal Investigator: Manisha Shah Memorial Sloan-Kettering Cancer Center
  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, NCI-5917, CDR0000304738, MSKCC-03032
Study First Received: June 5, 2003
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 July 23, 2014