Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight

Criteria

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