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

Information source: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapeutic Agent Toxicity; Pancreatic Cancer; Thromboembolism

Intervention: daltéparine (Drug); Chemotherapy at the investigator's discretion (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Official(s) and/or principal investigator(s):
Benoist Chibauldel, MD, Principal Investigator, Affiliation: Hopital Saint Antoine

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.

Clinical Details

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

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

Primary outcome: Thromboembolic events

Secondary outcome:

Progression-free survival

Overall survival

Tolerance of regimens

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Centre Hospitalier de Meaux, Meaux 77104, France

Centre Hospitalier Intercommunal Le Raincy - Montfermeil, Montfermeil 93370, France

CHU Pitie-Salpetriere, Paris 75651, France

Hopital Bichat - Claude Bernard, Paris 75018, France

Hopital Saint Antoine, Paris 75571, France

Hopital Foch, Suresnes 92151, France

Additional Information

Starting date: October 2007
Last updated: March 12, 2013

Page last updated: August 20, 2015

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