S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Medical Center
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Cancer Center
- Veterans Affairs Medical Center - Denver
- MBCCOP-Howard University Cancer Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- CCOP - Beaumont
- Providence Hospital - Southfield
- CCOP - Duluth
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Albany
- Herbert Irving Comprehensive Cancer Center
- University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Barrett Cancer Center, The University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- OHSU Cancer Institute
- Veterans Affairs Medical Center - Charleston
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Veterans Affairs Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
Arms of the Study
Arm 1
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