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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030862
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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
Esophageal Cancer Drug: cisplatin Drug: irinotecan hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.5 mg/dL
  • Calcium less than 12.0 mg/dL


  • 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


  • No interstitial pneumonia
  • No fibroid lung


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to the pelvis


  • See Disease Characteristics
  • Not specified


  • No concurrent phenytoin or phenobarbital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030862

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: David H. Ilson, MD, PhD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00030862    
Other Study ID Numbers: 01-123
CDR0000069204 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
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:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action