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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	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: irinotecan hydrochloride Procedure: computed tomography Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: positron emission tomography Radiation: fludeoxyglucose F 18	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer Surgery

Drug Information available for: Cisplatin Fluorodeoxyglucose F18 Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

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

Additional Information:

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

Publications:

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
Study First Received:	June 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00062374 History of Changes
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

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Irinotecan
Enzyme Inhibitors
Pharmacologic Actions
Camptothecin
Neoplasms

Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Radiation-Sensitizing Agents
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 09, 2009