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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Pancreatic Cancer, Thromboembolism

Intervention / Treatment
-----------------
* Drug: dalteparin
* Drug: gemcitabine hydrochloride
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: 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 Hematopoietic: 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 Hepatic: Bilirubin less than 2.0 mg/dL aspartate aminotransferase less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: 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 Other: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalteparin<br>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<br> <br> Drug: gemcitabine hydrochloride<br> <br> Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by FACT-Hep version 4 every 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Frequency of symptomatic venous thromboembolic complications |  |  | 
| Safety as measured by the occurrence of bleeding complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thromboembolism, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer