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

Pancreatic Cancer Clinical Trial

— PAM07  

Official title:

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

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

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Pancreatic Cancer
• Pancreatic Neoplasms
• Thromboembolism

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