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

This study has been terminated.
(recruitment prematurely stopped due to a lack of eligible patients.)
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00662688
First received: April 18, 2008
Last updated: March 12, 2013
Last verified: March 2013

April 18, 2008
March 12, 2013
October 2007
December 2012   (final data collection date for primary outcome measure)
Thromboembolic events [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]
number of thromboembolic events during anticoagulation treatment
Number of thromboembolic events [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00662688 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at one year ] [ Designated as safety issue: No ]
  • Tolerance of regimens [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • Thromboembolic-related survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to response of tumor [ Designated as safety issue: No ]
  • Tolerance of regimens [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Chemotherapeutic Agent Toxicity
  • Pancreatic Cancer
  • Thromboembolism
  • Drug: daltéparine
  • Drug: Chemotherapy at the investigator's discretion
  • Active Comparator: chemotherapy
    chemotherapy at investigator's discretion
    Intervention: Drug: Chemotherapy at the investigator's discretion
  • Experimental: dalteparin
    dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
    Interventions:
    • Drug: daltéparine
    • Drug: Chemotherapy at the investigator's discretion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00662688
CDR0000593019, GERCOR-PAM07-D07-2, EUDRACT 2007-002115-59, EU-20837, PFIZER-GERCOR-PAM07-D07-2
No
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Principal Investigator: Benoist Chibauldel, MD Hopital Saint Antoine
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP