S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
12. juni 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
61
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Mobile, Alabama, Forente stater, 36688
- MBCCOP - Gulf Coast
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85006-2726
- CCOP - Greater Phoenix
-
Phoenix, Arizona, Forente stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
-
Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
-
Tucson, Arizona, Forente stater, 85723
- Veterans Affairs Medical Center - Tucson
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
-
Little Rock, Arkansas, Forente stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
-
-
California
-
Duarte, California, Forente stater, 91010
- City of Hope Comprehensive Cancer Center
-
Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forente stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Los Angeles, California, Forente stater, 90073
- Veterans Affairs Medical Center - West Los Angeles
-
Martinez, California, Forente stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
-
Oakland, California, Forente stater, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center
-
Sacramento, California, Forente stater, 95817
- University of California Davis Medical Center
-
Santa Rosa, California, Forente stater, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, Forente stater, 80220
- Veterans Affairs Medical Center - Denver
-
Denver, Colorado, Forente stater, 80010
- University of Colorado Cancer Center
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20060
- MBCCOP-Howard University Cancer Center
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30342-1701
- CCOP - Atlanta Regional
-
Fort Gordon, Georgia, Forente stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96859-5000
- Tripler Army Medical Center
-
Honolulu, Hawaii, Forente stater, 96813-2424
- Cancer Research Center of Hawaii
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
-
Chicago, Illinois, Forente stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
-
Decatur, Illinois, Forente stater, 62526
- CCOP - Central Illinois
-
Hines, Illinois, Forente stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
-
Maywood, Illinois, Forente stater, 60153
- Loyola University Medical Center
-
-
Kansas
-
Kansas City, Kansas, Forente stater, 66160-7353
- University of Kansas Medical Center
-
Wichita, Kansas, Forente stater, 67214-3882
- CCOP - Wichita
-
Wichita, Kansas, Forente stater, 67218
- Veterans Affairs Medical Center - Wichita
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
Lexington, Kentucky, Forente stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
-
Shreveport, Louisiana, Forente stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
-
Shreveport, Louisiana, Forente stater, 71130
- Veterans Affairs Medical Center - Shreveport
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
-
Jamaica Plain, Massachusetts, Forente stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
-
Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
-
Ann Arbor, Michigan, Forente stater, 48109-0912
- University Of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, Forente stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
-
Grand Rapids, Michigan, Forente stater, 49503
- CCOP - Grand Rapids Clinical Oncology Program
-
Royal Oak, Michigan, Forente stater, 48073-6769
- CCOP - Beaumont
-
Southfield, Michigan, Forente stater, 48075-9975
- Providence Hospital - Southfield
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
-
-
Mississippi
-
Biloxi, Mississippi, Forente stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
-
Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
-
Jackson, Mississippi, Forente stater, 39216
- Veterans Affairs Medical Center - Jackson
-
Keesler AFB, Mississippi, Forente stater, 39534-2576
- Keesler Medical Center - Keesler AFB
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64128
- Veterans Affairs Medical Center - Kansas City
-
Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forente stater, 63141
- CCOP - St. Louis-Cape Girardeau
-
Saint Louis, Missouri, Forente stater, 63110
- St. Louis University Health Sciences Center
-
Springfield, Missouri, Forente stater, 65807
- CCOP - Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
-
Albuquerque, New Mexico, Forente stater, 87131
- MBCCOP - University of New Mexico HSC
-
-
New York
-
Albany, New York, Forente stater, 12208
- Veterans Affairs Medical Center - Albany
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center
-
Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
-
Cincinnati, Ohio, Forente stater, 45267-0501
- Barrett Cancer Center, The University Hospital
-
Cleveland, Ohio, Forente stater, 44195-9001
- Cleveland Clinic Taussig Cancer Center
-
Columbus, Ohio, Forente stater, 43206
- CCOP - Columbus
-
Dayton, Ohio, Forente stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Kettering, Ohio, Forente stater, 45429
- CCOP - Dayton
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma Medical Research Foundation
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
-
-
Oregon
-
Portland, Oregon, Forente stater, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Program
-
Portland, Oregon, Forente stater, 97239
- OHSU Cancer Institute
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425-0721
- Medical University of South Carolina
-
Charleston, South Carolina, Forente stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
-
Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
-
-
Texas
-
Fort Sam Houston, Texas, Forente stater, 78234-6200
- Brooke Army Medical Center
-
Galveston, Texas, Forente stater, 77555-0565
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, Forente stater, 77030-4095
- University of Texas - MD Anderson Cancer Center
-
San Antonio, Texas, Forente stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, Forente stater, 78284-7845
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, Forente stater, 76504
- Veterans Affairs Medical Center - Temple
-
Temple, Texas, Forente stater, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
-
Salt Lake City, Utah, Forente stater, 84112-5550
- Huntsman Cancer Institute
-
-
Washington
-
Seattle, Washington, Forente stater, 98101
- CCOP - Virginia Mason Research Center
-
Seattle, Washington, Forente stater, 98104
- Swedish Cancer Institute
-
Seattle, Washington, Forente stater, 98108
- Veterans Affairs Medical Center - Seattle
-
Tacoma, Washington, Forente stater, 98431-5000
- Madigan Army Medical Center
-
Tacoma, Washington, Forente stater, 98405-0986
- CCOP - Northwest
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Stephen K. Williamson, MD, University of Kansas
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2001
Primær fullføring (Faktiske)
1. april 2006
Studiet fullført (Faktiske)
1. april 2006
Datoer for studieregistrering
Først innsendt
3. mars 2001
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. juni 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2012
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Neoplasmer i magen
- Neoplasmer i spiserøret
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Gemcitabin
- Irinotekan
Andre studie-ID-numre
- CDR0000068515
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- S0101 (Annen identifikator: SWOG)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .