Pancreatic Cancer Clinical Trial
— PAM07Official title:
Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from
forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine
is more effective when given alone or together with dalteparin and/or capecitabine in
treating patients with pancreatic cancer.
PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots
in patients with pancreatic cancer receiving treatment with different combinations of
gemcitabine and capecitabine.
Status | Terminated |
Enrollment | 42 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Metastatic disease - Not amenable to treatment - No localized or locally advanced disease - Measurable disease (metastatic or primary tumor) defined as = 2 cm by CT scan or = 1 cm by spiral CT scan or MRI - No progressive thrombo-embolic disease - No adenocarcinoma of the biliary tract or ampulla of Vater - No known CNS metastases PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Life expectancy > 12 weeks - ANC = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 9 g/dL - Alkaline phosphatase < 5 times normal - Bilirubin < 1.5 times normal - Creatinine < 1.5 times normal - Creatinine clearance < 30 mL/min - Pain controlled or stabilized via analgesic therapy - Affiliation with social security system - Not pregnant or nursing - No controlled or uncontrolled jaundice - No contraindication to study drugs - No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months - No serious cardiac and/or respiratory disease - No other cancer in the past 5 years except the following cancers, provided they have been completely resected: - Skin cancer - Localized melanoma - Carcinoma in situ of the cervix - No history of thrombophilia - No history of heparin-induced thrombocytopenia - No uncontrolled or persistent hypercalcemia - No psychological, familial, social, and/or geographical condition that precludes participation in the study PRIOR CONCURRENT THERAPY: - No prior hematologic therapy for metastatic disease - No prior abdominal radiotherapy - No concurrent corticosteroids as anti-emetic therapy - No other concurrent anticoagulation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Meaux | Meaux | |
France | Centre Hospitalier Intercommunal Le Raincy - Montfermeil | Montfermeil | |
France | CHU Pitie-Salpetriere | Paris | |
France | Hopital Bichat - Claude Bernard | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Hopital Foch | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thromboembolic events | number of thromboembolic events during anticoagulation treatment | during study treatment | Yes |
Secondary | Progression-free survival | at 6 months | No | |
Secondary | Overall survival | at one year | No | |
Secondary | Tolerance of regimens | each cycle | Yes |
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