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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00662688
Other study ID # CDR0000593019
Secondary ID GERCOR-PAM07-D07
Status Terminated
Phase Phase 3
First received April 18, 2008
Last updated March 12, 2013
Start date October 2007
Est. completion date December 2012

Study information

Verified date March 2013
Source Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

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


Intervention

Drug:
daltéparine

Chemotherapy at the investigator's discretion


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

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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