NCT00031837

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreatic Cancer
• Thromboembolism

Interventions

Type	Name	Description
DRUG	dalteparin
DRUG	gemcitabine hydrochloride
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2002-10-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2003-01-27
• Last updated: 2015-10-14

Locations

13 sites across 1 country: United States