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A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer, Thromboembolism

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Trial Information

A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer


- 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

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.

Inclusion Criteria


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



- 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

Type of Study:


Study Design:

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

Outcome Measure:

Quality of life as measured by FACT-Hep version 4 every 4 weeks

Safety Issue:


Principal Investigator

Kishan J. Pandya, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

December 2006

Related Keywords:

  • Pancreatic Cancer
  • Thromboembolism
  • thromboembolism
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms
  • Thromboembolism



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