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Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00031837
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : October 14, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Thromboembolism Drug: dalteparin Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Phase 3

Detailed Description:


  • Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.
  • Compare the survival of patients treated with these regimens.
  • Compare the incidence of venous thromboembolic complications in patients treated with these regimens.
  • Determine the safety of dalteparin, in terms of bleeding complications, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.
  • Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and every 4 weeks during study therapy.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
Study Start Date : October 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dalteparin
5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.
Drug: dalteparin
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment

Primary Outcome Measures :
  1. Quality of life as measured by FACT-Hep version 4 every 4 weeks

Secondary Outcome Measures :
  1. Survival
  2. Frequency of symptomatic venous thromboembolic complications
  3. Safety as measured by the occurrence of bleeding complications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection



  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group 0-2

Life expectancy:

  • Not specified


  • White Blood Cell count greater than 3,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No clinically significant bleeding disorder
  • No prior heparin-induced thrombocytopenia


  • Bilirubin less than 2.0 mg/dL
  • aspartate aminotransferase less than 3 times normal


  • Creatinine less than 2.0 mg/dL


  • No prior hemorrhagic stroke
  • No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy
  • No gastrointestinal bleeding within the past 30 days
  • No contraindications to anticoagulation


Biologic therapy:

  • Not specified


  • No prior chemotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • Prior surgical resection allowed
  • At least 4 weeks since prior surgery with non-curative intent and recovered
  • More than 30 days since prior neurologic or ophthalmologic surgery


  • At least 2 weeks since prior low-molecular-weight heparin
  • More than 30 days since prior experimental therapeutic agent
  • No concurrent heparin or warfarin for pre-existing condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031837

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United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
University of Rochester Cancer Center CCOP Research Base
Rochester, New York, United States, 14642
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
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Study Chair: Kishan J. Pandya, MD University of Rochester
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Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
ClinicalTrials.gov Identifier: NCT00031837    
Other Study ID Numbers: CDR0000069232
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Gary Morrow, University of Rochester:
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents