Chemotherapy With Or Without Dalteparin In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

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

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.

Chemotherapeutic Agent Toxicity
Pancreatic Cancer
Thromboembolism

DRUG: daltéparine
DRUG: Chemotherapy at the investigator's discretion

CDR0000593019
GERCOR-PAM07-D07-2
EUDRACT 2007-002115-59
EU-20837
PFIZER-GERCOR-PAM07-D07-2

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-03-12
First Submitted that Met QC Criteria 2008-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-03-13
First Posted (ESTIMATED) 2008-04-21	Results First Posted N/A	Last Verified 2013-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
Thromboembolic events	number of thromboembolic events during anticoagulation treatment	during study treatment

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival		at 6 months
Overall survival		at one year
Tolerance of regimens		each cycle

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Benoist Chibauldel, MD, Hopital Saint Antoine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

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Clinical Trial Record