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S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent 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: NCT00012363
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 14, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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 combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Phase 2

Detailed Description:


  • Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II
Study Start Date : April 2001
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Arm Intervention/treatment
Experimental: Gemcitabine + Irinotecan
Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days
Drug: gemcitabine hydrochloride
1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
Other Name: Gemzar (NSC-613327)

Drug: irinotecan hydrochloride
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Other Name: CPT-11 (NSC-616348)

Primary Outcome Measures :
  1. 6-month survival rate [ Time Frame: 6 months after registration ]
    To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.

Secondary Outcome Measures :
  1. Toxicities [ Time Frame: Week 1 and Week 2 of each cycle ]
    To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study.

Information from the National Library of Medicine

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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 metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction

    • Squamous cell carcinoma OR
    • Adenocarcinoma
  • No known brain metastases



  • 18 to 100

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


  • Creatinine no greater than 1.5 times upper limit of normal


  • No uncontrolled hypertension
  • No unstable angina
  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious uncontrolled cardiac arrhythmia


  • No active inflammatory bowel disease
  • No significant bowel obstruction
  • No chronic diarrhea


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active infection requiring systemic therapy
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission


Biologic therapy:

  • At least 28 days since prior biologic therapy
  • No prior biologic therapy for metastatic or recurrent disease
  • No concurrent sargramostim (GM-CSF)
  • No concurrent immunotherapy for tumor


  • At least 28 days since prior chemotherapy
  • No prior chemotherapy for metastatic or recurrent disease
  • No prior gemcitabine or irinotecan
  • Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
  • No other concurrent chemotherapy for tumor

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior endocrine therapy
  • No prior endocrine therapy for metastatic or recurrent disease
  • No concurrent hormonal therapy for tumor


  • At least 28 days since prior radiotherapy
  • No prior radiotherapy for metastatic or recurrent disease
  • Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
  • No concurrent radiotherapy for tumor


  • Prior thoraco-abdominal surgery allowed
  • At least 3 weeks since prior surgery and recovered


  • No other concurrent anti-cancer therapy for tumor

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): NCT00012363

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Stephen K. Williamson, MD University of Kansas
Publications of Results:
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Responsible Party: Southwest Oncology Group Identifier: NCT00012363    
Other Study ID Numbers: CDR0000068515
S0101 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Keywords provided by Southwest Oncology Group:
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors