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Home > "G" Clinical Trials Conditions > Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

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



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

For Condition: recurrent gastric cancer,Adenocarcinoma of the Esophagus,stage 4 esophageal cancer,squamous cell carcinoma of the esophagus,recurrent esophageal cancer,stage 4 gastric cancer,adenocarcinoma of the stomach
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StephenWilliamson,  Study Chair,  University of Kansas

Veterans Affairs Outpatient Clinic - Martinez
Martinez,  California,  94553
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97225
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

Tripler Army Medical Center
Honolulu,  Hawaii,  96859-5000
United States
 

Providence Hospital - Southfield
Southfield,  Michigan,  48075-9975
United States
 

Veterans Affairs Medical Center - Oklahoma City
Oklahoma City,  Oklahoma,  73104
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813-2424
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

MBCCOP-Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

OHSU Cancer Institute
Portland,  Oregon,  97239
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112-5550
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

Veterans Affairs Medical Center - Jackson
Jackson,  Mississippi,  39216
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

Veterans Affairs Medical Center - Temple
Temple,  Texas,  76504
United States
 

Veterans Affairs Medical Center - Seattle
Seattle,  Washington,  98108
United States
 

Veterans Affairs Medical Center - Charleston
Charleston,  South Carolina,  29401-5799
United States
 

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

Veterans Affairs Medical Center - Shreveport
Shreveport,  Louisiana,  71130
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195-9001
United States
 

Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock,  Arkansas,  72205
United States
 

Veterans Affairs Medical Center - Kansas City
Kansas City,  Missouri,  64128
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0565
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

Keesler Medical Center - Keesler AFB
Keesler AFB,  Mississippi,  39534-2576
United States
 

CCOP - Beaumont
Royal Oak,  Michigan,  48073-6769
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4095
United States
 

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

University of California Davis Medical Center
Sacramento,  California,  95817
United States
 

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0912
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Veterans Affairs Medical Center - Biloxi
Biloxi,  Mississippi,  39531-2410
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Dwight David Eisenhower Army Medical Center
Fort Gordon,  Georgia,  30905-5650
United States
 

Veterans Affairs Medical Center - Lexington
Lexington,  Kentucky,  40502-2236
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

Veterans Affairs Medical Center - West Los Angeles
Los Angeles,  California,  90073
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

Veterans Affairs Medical Center - Dayton
Dayton,  Ohio,  45428
United States
 

Veterans Affairs Medical Center - Tucson
Tucson,  Arizona,  85723
United States
 

Veterans Affairs Medical Center - Denver
Denver,  Colorado,  80220
United States
 

Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain,  Massachusetts,  02130
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

University of Kansas Medical Center
Kansas City,  Kansas,  66160-7353
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio,  Texas,  78284
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

Veterans Affairs Medical Center - Salt Lake City
Salt Lake City,  Utah,  84148
United States
 

Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

Veterans Affairs Medical Center - Ann Arbor
Ann Arbor,  Michigan,  48105
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

Veterans Affairs Medical Center - Cincinnati
Cincinnati,  Ohio,  45220-2288
United States
 

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234-6200
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Veterans Affairs Medical Center - Detroit
Detroit,  Michigan,  48201-1932
United States
 

Herbert Irving Comprehensive Cancer Center
New York City,  New York,  10032
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

Veterans Affairs Medical Center - Albuquerque
Albuquerque,  New Mexico,  87108-5138
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45267-0501
United States
 

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033-0804
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines,  Illinois,  60141
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

Veterans Affairs Medical Center - Portland
Portland,  Oregon,  97207
United States
 

Veterans Affairs Medical Center - Houston
Houston,  Texas,  77030
United States
 

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix,  Arizona,  85012
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80010
United States
 

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7845
United States
 

Loyola University Medical Center
Maywood,  Illinois,  60153
United States
 

CCOP - Atlanta Regional
Atlanta,  Georgia,  30342-1701
United States
 

CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids,  Michigan,  49503
United States
 

Oklahoma Medical Research Foundation
Oklahoma City,  Oklahoma,  73104
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068515;  SWOG-S0101
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012363

Other Stage 4 Gastric Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Stomach Cancer

2. Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer

3. Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

4. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

5. Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach Cancer

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

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