Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer

April 24, 2009 updated by: Dana-Farber Cancer Institute

A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer

This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Taxotere, cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks).
  • Patients will also receive corticosteroids, intravenous hydration and anti-emetic therapy prior to each treatment.
  • A physical exam and bloodwork will be done each week of the treatment and every 2 cycles, reassessment of the tumor by the same imaging method to determine the baseline size will be conducted.
  • Patients will remain on the study unless disease progression or intolerable toxicity occur.

Study Type

Interventional

Enrollment (Actual)

54

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02130
        • Faulkner Hospital

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

Inclusion Criteria:

  • Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma = adenocarcinoma or squamous cell carcinoma)
  • Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other radiographic technique.
  • Lesions must be measurable in at least one dimension.
  • Bone lesions, ascites and effusions are not measurable.
  • Irradiated lesions are not measurable yet lesions arising in previously irradiated fields are measurable.
  • Age 18+ years.
  • ECOG performance status 0 or 1.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function.
  • Adequate renal function: creatinine equal to or less than 1.5 mg/dl.
  • SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is within institutional upper limit of normal.
  • Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within institutional upper limit of normal.
  • For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less 2.5 x institutional upper limit of normal. For patients with liver metastases, however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline phosphatase may be < 5.0 x institutional upper limit of normal as long as the total bilirubin is within the institutional upper limit of normal.

Exclusion Criteria:

  • No prior chemotherapy (except as part of pre- or post-operative therapy, completed > 1 year prior to start date of this protocol).
  • Patients who have received prior pelvic radiation therapy are ineligible. Other prior radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since completion of this therapy and the initiation of this protocol.
  • No myocardial infarction in the past six months.
  • No major surgery in the past three weeks.
  • No uncontrolled serious medical or psychiatric illness.
  • No uncontrolled diarrhea.
  • Patients with a peripheral neuropathy > grade 1 will be excluded.
  • Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must use adequate contraception.
  • No clinically apparent central nervous system metastases or carcinomatous meningitis.
  • No other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.
  • Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or drugs formulated with polysorbate 80 must be excluded.

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.
To assess the toxicity of this combination in esophageal or gastric carcinoma.
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2001

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-140

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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