- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36607
- MBCCOP - Gulf Coast
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Colorado
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Denver, Colorado, États-Unis, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Illinois
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Chicago, Illinois, États-Unis, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, États-Unis, 62526
- CCOP - Central Illinois
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Michigan
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Kalamazoo, Michigan, États-Unis, 49007-3731
- CCOP - Kalamazoo
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Missouri
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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New York
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East Syracuse, New York, États-Unis, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Rochester, New York, États-Unis, 14642
- University of Rochester Cancer Center CCOP Research Base
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North Carolina
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Goldsboro, North Carolina, États-Unis, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Columbus, Ohio, États-Unis, 43215
- CCOP - Columbus
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Dayton, Ohio, États-Unis, 45429
- CCOP - Dayton
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South Carolina
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Washington
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Tacoma, Washington, États-Unis, 98405-0986
- CCOP - Northwest
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Quality of life as measured by FACT-Hep version 4 every 4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
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Survie
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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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Kishan J. Pandya, MD, University of Rochester
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Maladies cardiovasculaires
- Maladies vasculaires
- Tumeurs
- Tumeurs par site
- Maladies du système endocrinien
- Tumeurs du système digestif
- Tumeurs des glandes endocrines
- Embolie et thrombose
- Maladies pancréatiques
- Tumeurs pancréatiques
- Thromboembolie
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Inhibiteurs d'enzymes
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Anticoagulants
- Gemcitabine
- Héparine de bas poids moléculaire
- Tinzaparine
- Daltéparine
Autres numéros d'identification d'étude
- CDR0000069232
- URCC-U2200
- NCI-5012
- NCI-CCC-99-45
- NCI-P02-0212
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