- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Alabama
-
Mobile, Alabama, Förenta staterna, 36607
- MBCCOP - Gulf Coast
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612-7323
- MBCCOP - University of Illinois at Chicago
-
Decatur, Illinois, Förenta staterna, 62526
- CCOP - Central Illinois
-
-
Michigan
-
Kalamazoo, Michigan, Förenta staterna, 49007-3731
- CCOP - Kalamazoo
-
-
Missouri
-
Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
-
-
New York
-
East Syracuse, New York, Förenta staterna, 13057
- CCOP - Hematology-Oncology Associates of Central New York
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester Cancer Center CCOP Research Base
-
-
North Carolina
-
Goldsboro, North Carolina, Förenta staterna, 27534-9479
- CCOP - Southeast Cancer Control Consortium
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43215
- CCOP - Columbus
-
Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
-
-
South Carolina
-
Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
-
-
Washington
-
Tacoma, Washington, Förenta staterna, 98405-0986
- CCOP - Northwest
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Quality of life as measured by FACT-Hep version 4 every 4 weeks
|
Sekundära resultatmått
Resultatmått |
---|
Överlevnad
|
Frequency of symptomatic venous thromboembolic complications
|
Safety as measured by the occurrence of bleeding complications
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Kishan J. Pandya, MD, University of Rochester
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Sjukdomar i det endokrina systemet
- Neoplasmer i matsmältningssystemet
- Neoplasmer i endokrina körtel
- Embolism och trombos
- Bukspottkörtelsjukdomar
- Pankreatiska neoplasmer
- Tromboembolism
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Fibrinolytiska medel
- Fibrinmodulerande medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antikoagulantia
- Gemcitabin
- Heparin, lågmolekylär vikt
- Tinzaparin
- Dalteparin
Andra studie-ID-nummer
- CDR0000069232
- URCC-U2200
- NCI-5012
- NCI-CCC-99-45
- NCI-P02-0212
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bukspottskörtelcancer
-
Tianjin Medical University Cancer Institute and...Har inte rekryterat ännuPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekryteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Cedars-Sinai Medical CenterRekryteringPDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
-
Radboud University Medical CenterDutch Cancer SocietyRekryteringPDAC - Pancreatic Ductal AdenocarcinomaNederländerna
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... och andra samarbetspartnersRekryteringBukspottskörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaStorbritannien
-
Chinese PLA General HospitalRekryteringPankreatiska neoplasmer | Bukspottskörtelcancer | Bukspottkörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaKina
-
Andrei IagaruInte längre tillgängligKarcinoida tumörer | Islet Cell (Pancreatic NET) | Andra neuroendokrina tumörerFörenta staterna
-
Mayo ClinicRekryteringBukspottskörtelcancer | Duktalt adenokarcinom i bukspottkörteln | PDAC | PDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
Kliniska prövningar på gemcitabinhydroklorid
-
M.D. Anderson Cancer CenterIndragenMetastaserande icke-småcelligt lungkarcinom | Steg IVA lungcancer AJCC v8 | Steg IVB lungcancer AJCC v8 | Steg IV lungcancer AJCC v8
-
Sierra Oncology LLC - a GSK companyAvslutadAvancerade solida tumörerSpanien, Storbritannien
-
University of Erlangen-Nürnberg Medical SchoolAvslutadBukspottskörtelcancerTyskland
-
AstraZenecaRekryteringGallvägscancerFrankrike, Spanien, Italien, Korea, Republiken av, Japan, Tyskland, Förenta staterna, Singapore
-
Shenzhen University General HospitalHar inte rekryterat ännu
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekrytering
-
Kansai Hepatobiliary Oncology GroupAvslutad
-
3D Medicines (Sichuan) Co., Ltd.Har inte rekryterat ännuNeoplasmer i gallvägarna
-
Samsung Medical CenterAvslutadBukspottskörtelcancerKorea, Republiken av
-
University of ZurichAvslutadBukspottskörtelcancerFrankrike, Schweiz, Belgien, Tyskland