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Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00030862
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
26
Duration (Months)

Study Details

Study Description

Brief Summary

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 combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin.

  • Determine the dysphagia relief in patients treated with this regimen.

  • Determine the time to progression and overall survival of patients treated with this regimen.

  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer
Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Dec 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus

    • Previously untreated

    • Locally advanced unresectable or metastatic disease

    • More than 50% of tumor must involve esophagus or gastroesophageal (GE) junction if tumor extends below the GE junction into the proximal stomach

    • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR

    • At least 10 mm by spiral CT scan

    • The following are not considered measurable disease:

    • Bone lesions

    • Leptomeningeal disease

    • Ascites

    • Pleural/pericardial effusions

    • Lymphangitis cutis/pulmonis

    • Abdominal masses not confirmed and followed by imaging techniques

    • Cystic lesions

    • Tumor lesions in previously irradiated areas

    • No carcinomatous meningitis or untreated brain metastases

    • Brain metastases allowed if asymptomatic and patient is on stable or tapering dose of steroids

    • Large pleural effusions must have been previously drained and sclerosed or otherwise controlled

    • Small, stable, asymptomatic pleural effusions allowed

    • Dysphagia allowed

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:

    • ECOG 0-2 OR

    • Karnofsky 60-100%

    Life expectancy:
    • At least 3 months
    Hematopoietic:

    • Absolute neutrophil count at least 1,500/mm^3

    • WBC at least 3,000/mm^3

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

    Hepatic:

    • Bilirubin no greater than 1.5 mg/dL

    • AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

    • No known Gilbert's disease

    Renal:

    • Creatinine no greater than 1.5 mg/dL

    • Calcium less than 12.0 mg/dL

    Cardiovascular:

    • No history of significant cardiovascular disease

    • No inadequately controlled hypertension

    • No unstable angina

    • No myocardial infarction within the past 6 months

    • No ventricular cardiac arrhythmias requiring medication

    • No history or treatment for congestive heart failure

    Pulmonary:

    • No interstitial pneumonia

    • No fibroid lung

    Other:

    • No serious active infection

    • No uncontrolled diabetes mellitus (random blood sugar at least 300 mg)

    • No peripheral neuropathy grade 2 or greater

    • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy that does not carry a worse prognosis than advanced esophageal cancer

    • No other serious underlying medical condition that would preclude study

    • No other concurrent disease that would preclude study

    • No psychiatric illness or other significant mental impairment that would preclude study

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • No prior chemotherapy
    Endocrine therapy:
    • See Disease Characteristics
    Radiotherapy:

    • See Disease Characteristics

    • At least 2 weeks since prior radiotherapy and recovered

    • No prior radiotherapy to the pelvis

    Surgery:

    • See Disease Characteristics

    • Not specified

    Other:
    • No concurrent phenytoin or phenobarbital

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00030862
    Other Study ID Numbers:
    • 01-123
    • CDR0000069204
    • PHARMACIA-440E-ONC-0020-319
    • NCI-G01-2050
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 5, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by , ,
    stage II esophageal cancer
    stage III esophageal cancer
    stage IV esophageal cancer
    squamous cell carcinoma of the esophagus
    adenocarcinoma of the esophagus
    Additional relevant MeSH terms:
    Esophageal Neoplasms
    Irinotecan

    Study Results

    No Results Posted as of Jun 5, 2013