Know Cancer

forgot password

Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas

Phase 3
18 Years
80 Years
Not Enrolling
Chemotherapeutic Agent Toxicity, Pancreatic Cancer, Thromboembolism

Thank you

Trial Information

Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas



- To demonstrate that preventive anticoagulation with dalteparin reduces the number of
thromboembolic events.

- To determine the number of thromboembolic events occurring with preventive


- To determine survival without thrombotic event.

- To determine progression-free and overall survival.

- To determine time to response of tumor.

- To assess tolerance of these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment

- Arm A: Patients receive chemotherapy at investigator's discretion

- Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all
arms, treatment repeats in the absence of disease progression or unacceptable toxicity.

Blood and plasma samples are obtained at baseline and periodically during study. Blood is
examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor,
mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are
assessed in plasma.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


- 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


- 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


- No prior hematologic therapy for metastatic disease

- No prior abdominal radiotherapy

- No concurrent corticosteroids as anti-emetic therapy

- No other concurrent anticoagulation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Thromboembolic events

Outcome Description:

number of thromboembolic events during anticoagulation treatment

Outcome Time Frame:

during study treatment

Safety Issue:


Principal Investigator

Benoist Chibauldel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Saint Antoine


France: Agence Nationale de Sécurité du Médicament

Study ID:




Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Pancreatic Cancer
  • Thromboembolism
  • thromboembolism
  • chemotherapeutic agent toxicity
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms
  • Thromboembolism