S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
12. juni 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
61
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20060
- MBCCOP-Howard University Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forenede Stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, Forenede Stater, 48109-0912
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, Forenede Stater, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Forenede Stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267-0501
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Program
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Portland, Oregon, Forenede Stater, 97239
- OHSU Cancer Institute
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Forenede Stater, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, Forenede Stater, 77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Forenede Stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Forenede Stater, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forenede Stater, 84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Forenede Stater, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
Andre navne:
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6-month survival rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Toxicities
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Stephen K. Williamson, MD, University of Kansas
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2001
Primær færdiggørelse (Faktiske)
1. april 2006
Studieafslutning (Faktiske)
1. april 2006
Datoer for studieregistrering
Først indsendt
3. marts 2001
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2012
Sidst verificeret
1. juni 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Neoplasmer i maven
- Esophageale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Gemcitabin
- Irinotecan
Andre undersøgelses-id-numre
- CDR0000068515
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S0101 (Anden identifikator: SWOG)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .