- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00031837
Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.
- Compare the survival of patients treated with these regimens.
- Compare the incidence of venous thromboembolic complications in patients treated with these regimens.
- Determine the safety of dalteparin, in terms of bleeding complications, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and every 4 weeks during study therapy.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Alabama
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Mobile, Alabama, Forente stater, 36607
- MBCCOP - Gulf Coast
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Colorado
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Denver, Colorado, Forente stater, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Illinois
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Chicago, Illinois, Forente stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, Forente stater, 62526
- CCOP - Central Illinois
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Michigan
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Kalamazoo, Michigan, Forente stater, 49007-3731
- CCOP - Kalamazoo
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Missouri
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Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
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New York
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East Syracuse, New York, Forente stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Rochester, New York, Forente stater, 14642
- University of Rochester Cancer Center CCOP Research Base
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North Carolina
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Goldsboro, North Carolina, Forente stater, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Columbus, Ohio, Forente stater, 43215
- CCOP - Columbus
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Dayton, Ohio, Forente stater, 45429
- CCOP - Dayton
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
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Washington
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Tacoma, Washington, Forente stater, 98405-0986
- CCOP - Northwest
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group 0-2
Life expectancy:
- Not specified
Hematopoietic:
- White Blood Cell count greater than 3,500/mm^3
- Platelet count greater than 100,000/mm^3
- No clinically significant bleeding disorder
- No prior heparin-induced thrombocytopenia
Hepatic:
- Bilirubin less than 2.0 mg/dL
- aspartate aminotransferase less than 3 times normal
Renal:
- Creatinine less than 2.0 mg/dL
Cardiovascular:
- No prior hemorrhagic stroke
- No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy
- No gastrointestinal bleeding within the past 30 days
- No contraindications to anticoagulation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Prior surgical resection allowed
- At least 4 weeks since prior surgery with non-curative intent and recovered
- More than 30 days since prior neurologic or ophthalmologic surgery
Other:
- At least 2 weeks since prior low-molecular-weight heparin
- More than 30 days since prior experimental therapeutic agent
- No concurrent heparin or warfarin for pre-existing condition
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Dalteparin
5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.
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Hva måler studien?
Primære resultatmål
Resultatmål |
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Quality of life as measured by FACT-Hep version 4 every 4 weeks
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Sekundære resultatmål
Resultatmål |
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Overlevelse
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Frequency of symptomatic venous thromboembolic complications
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Safety as measured by the occurrence of bleeding complications
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Kishan J. Pandya, MD, University of Rochester
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdommer i det endokrine systemet
- Neoplasmer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Embolisme og trombose
- Pankreassykdommer
- Neoplasmer i bukspyttkjertelen
- Tromboemboli
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antikoagulanter
- Gemcitabin
- Heparin, lavmolekylær vekt
- Tinzaparin
- Dalteparin
Andre studie-ID-numre
- CDR0000069232
- URCC-U2200
- NCI-5012
- NCI-CCC-99-45
- NCI-P02-0212
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. .
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