Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer

June 20, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the response rate of combined cisplatin and irinotecan in patients with metastatic or locally advanced (inoperable or recurrent) esophageal or gastric cancer. II. Evaluate the toxic effects both qualitatively and quantitatively of cisplatin and irinotecan in these patients. III. Estimate the disease free and overall survival of these patients. IV. Assess whether the response proportion differs between squamous cell and adenocarcinoma of the esophagus. V. Evaluate quality of life issues using the Memorial Symptom Assessment Scale, the FACT-G questionnaire, and the dysphagia scale.

OUTLINE: Patients receive cisplatin and irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. Each treatment course lasts 6 weeks. Patients receive at least 3 courses of therapy if the treatment is well tolerated and no disease progression is documented. Patients attaining a complete response receive additional courses of therapy at the discretion of the investigator. Tumor status is reassessed at 6 weeks and every 12 weeks thereafter. Patients are followed until death.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued within 12-18 months. Accrual for adenocarcinoma of the esophagus is complete.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven locally advanced (surgically unresectable) or metastatic squamous cell of the esophagus or carcinoma of the stomach Patients with tumor extension below the GE junction into the proximal stomach must have the bulk of the tumor involve the esophagus or GE junction Bidimensionally measurable or evaluable disease No CNS metastases or carcinomatous meningitis No bone metastases (Closed to adenocarcinoma of the esophagus as of 05/1998)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN)(no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No unstable angina No New York Heart Association class III or IV cardiac disease Pulmonary: No interstitial pulmonary fibrosis Other: Not pregnant or nursing Negative pregnancy test No active or uncontrolled infection No prior malignancy for at least 5 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiation to the pelvis Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David H. Ilson, MD, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 29, 2004

First Posted (Estimate)

July 30, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-060
  • CDR0000065703 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G97-1306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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