S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

June 12, 2012 updated by: Southwest Oncology Group

Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Enrollment (Actual)

61

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
    • Alabama
      • Mobile, Alabama, United States, 36688
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP-Howard University Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, United States, 96813-2424
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7353
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, United States, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Ann Arbor, Michigan, United States, 48109-0912
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, United States, 48075-9975
        • Providence Hospital - Southfield
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler AFB, Mississippi, United States, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Health Sciences Center
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Albany, New York, United States, 12208
        • Veterans Affairs Medical Center - Albany
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, United States, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Program
      • Portland, Oregon, United States, 97239
        • OHSU Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, United States, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • San Antonio, Texas, United States, 78284-7845
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Tacoma, Washington, United States, 98431-5000
        • Madigan Army Medical Center
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

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 confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction

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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 100

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

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

Gastrointestinal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • 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

Surgery:

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

Other:

  • No other concurrent anti-cancer therapy for tumor

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Gemzar (NSC-613327)
Drug: irinotecan hydrochloride
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Other Names:
  • CPT-11 (NSC-616348)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 and Week 2 of each cycle

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Stephen K. Williamson, MD, University of Kansas

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

April 1, 2001

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

March 3, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068515
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0101 (Other Identifier: SWOG)

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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