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

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer; Thromboembolism

Intervention: dalteparin (Drug); gemcitabine hydrochloride (Drug); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Terminated

Sponsored by: Gary Morrow

Official(s) and/or principal investigator(s):
Kishan J. Pandya, MD, Study Chair, Affiliation: University of Rochester


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.

Clinical Details

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

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

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

Secondary outcome:


Frequency of symptomatic venous thromboembolic complications

Safety as measured by the occurrence of bleeding complications

Detailed description: OBJECTIVES:

- 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly

differentiated carcinoma of the pancreas that is considered ineligible for curative resection PATIENT CHARACTERISTICS: Age:

- 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) Other:

- 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


- 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

Locations and Contacts

MBCCOP - Gulf Coast, Mobile, Alabama 36607, United States

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York 13057, United States

University of Rochester Cancer Center CCOP Research Base, Rochester, New York 14642, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Additional Information

Starting date: October 2002
Last updated: March 4, 2013

Page last updated: August 20, 2015

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