search
Back to results

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

Primary Purpose

Pancreatic Cancer, Thromboembolism

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
dalteparin
gemcitabine hydrochloride
diagnostic laboratory biomarker analysis
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring thromboembolism, stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage II pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Sites / Locations

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Royal Lancaster Infirmary
  • Saint Bartholomew's Hospital
  • St. George's Hospital
  • Maidstone Hospital
  • Nottingham City Hospital
  • Scarborough General Hospital
  • Scunthorpe General Hospital

Outcomes

Primary Outcome Measures

Incidence of venous thromboembolism reduction

Secondary Outcome Measures

Early survival benefit
Toxicity
Overall survival
Time to disease progression
Effect of drug combination on serological markers of thromboangiogenesis

Full Information

First Posted
April 18, 2007
Last Updated
August 9, 2013
Sponsor
Hull University Teaching Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT00462852
Brief Title
Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Thromboembolism
Keywords
thromboembolism, stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage II pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dalteparin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Incidence of venous thromboembolism reduction
Secondary Outcome Measure Information:
Title
Early survival benefit
Title
Toxicity
Title
Overall survival
Title
Time to disease progression
Title
Effect of drug combination on serological markers of thromboangiogenesis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Maraveyas
Organizational Affiliation
Hull University Teaching Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
State/Province
England
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33337539
Citation
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.
Results Reference
derived
PubMed Identifier
22100906
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs