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Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer (PAM07)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00662688
Recruitment Status : Terminated (recruitment prematurely stopped due to a lack of eligible patients.)
First Posted : April 21, 2008
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Chemotherapeutic Agent Toxicity Pancreatic Cancer Thromboembolism Drug: daltéparine Drug: Chemotherapy at the investigator's discretion Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events.
  • To determine the number of thromboembolic events occurring with preventive anticoagulation.

Secondary

  • 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 arms.

  • 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
Study Start Date : October 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: chemotherapy
chemotherapy at investigator's discretion
Drug: Chemotherapy at the investigator's discretion
Experimental: dalteparin
dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
Drug: daltéparine Drug: Chemotherapy at the investigator's discretion


Outcome Measures

Primary Outcome Measures :
  1. Thromboembolic events [ Time Frame: during study treatment ]
    number of thromboembolic events during anticoagulation treatment


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 6 months ]
  2. Overall survival [ Time Frame: at one year ]
  3. Tolerance of regimens [ Time Frame: each cycle ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662688


Locations
France
Centre Hospitalier de Meaux
Meaux, France, 77104
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, France, 93370
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Principal Investigator: Benoist Chibauldel, MD Hopital Saint Antoine
More Information

Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT00662688     History of Changes
Other Study ID Numbers: CDR0000593019
GERCOR-PAM07-D07-2
EUDRACT 2007-002115-59
EU-20837
PFIZER-GERCOR-PAM07-D07-2
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
thromboembolism
chemotherapeutic agent toxicity
adenocarcinoma of the pancreas
stage IV pancreatic cancer
recurrent pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Thromboembolism
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action