Gemcitabine With Or Without Dalteparin In Treating Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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 gemcitabine for pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or without dalteparin in treating patients with locally advanced or metastatic pancreatic cancer.

OBJECTIVES: Primary * Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus gemcitabine hydrochloride alone. Secondary * Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12 weeks, of patients treated with these regimens. * Compare the toxicity of these regimens. * Compare the overall survival of patients treated with these regimens. * Compare the time to disease progression in patients treated with these regimens. * Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers of thromboangiogenesis. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80% vs < 80%). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 and 9-11. * Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I. Blood samples are acquired at baseline for analysis of circulating tissue factor and vascular endothelial growth factor. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Pancreatic Cancer
Thromboembolism

DRUG: dalteparin
DRUG: gemcitabine hydrochloride
OTHER: diagnostic laboratory biomarker analysis

PRH-HCTU-FRAGEM
CDR0000540180 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
PRH-HCTU-FRAGEM-V-12.1
CTA-MF8000/13558
EU-20721
LILLY-PRH-HCTU-FRAGEM
ISRCTN76464767

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 2007-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-08-09
First Submitted that Met QC Criteria 2007-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-08-12
First Posted (ESTIMATED) 2007-04-19	Results First Posted N/A	Last Verified 2007-04

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:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Incidence of venous thromboembolism reduction

Secondary Outcome Measures	Measure Description	Time Frame
Early survival benefit
Toxicity
Overall survival
Time to disease progression
Effect of drug combination on serological markers of thromboangiogenesis

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 or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas

Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
Measurable or evaluable disease
No clinical evidence of active venous thromboembolism

Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
Life expectancy > 12 weeks
Absolute neutrophil count > 2,000/mm³
WBC > 3,000/mm³
Platelet count > 100,000/mm³
Creatinine clearance > 50 mL/min
INR ≤ 1.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN (stent allowed)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No cerebrovascular accident within the past 6 months
No obvious contraindication to anticoagulation, including the following:

Bleeding diathesis
Active peptic ulcer
Ulcerating cancer into duodenum
No history of other advanced malignancy
No gross hematuria
No melaena or gross evidence of gastrointestinal bleeding (other than piles)
No requirement for a central line
No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation

No prior gemcitabine hydrochloride-containing treatment
No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
No other concurrent specific anticancer therapy as a result of disease progression
No concurrent caval filter device
No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
No concurrent acetylsalicylic acid (> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
No concurrent clopidogrel bisulfate

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Anthony Maraveyas, Hull University Teaching Hospitals NHS Trust

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.
Maraveyas A, Waters J, Roy R, Fyfe D, Propper D, Lofts F, Sgouros J, Gardiner E, Wedgwood K, Ettelaie C, Bozas G. Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. Eur J Cancer. 2012 Jun;48(9):1283-92. doi: 10.1016/j.ejca.2011.10.017. Epub 2011 Nov 17.

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