Gemcitabine With Or Without Dalteparin In Treating Patients With Unresectable Or Metastatic Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer
Thromboembolism

DRUG: dalteparin
DRUG: gemcitabine hydrochloride
PROCEDURE: quality-of-life assessment

CDR0000069232
URCC-U2200
NCI-5012
NCI-CCC-99-45
NCI-P02-0212

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-10-13
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-10-14
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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	DRUG: dalteparin DRUG: gemcitabine hydrochloride PROCEDURE: quality-of-life assessment

Participant Group/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

DRUG: dalteparin

DRUG: gemcitabine hydrochloride

PROCEDURE: quality-of-life assessment

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

Eastern Cooperative Oncology Group 0-2

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

Not specified

No prior chemotherapy for metastatic disease
Prior adjuvant chemotherapy allowed

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Kishan J. Pandya, MD, University of Rochester

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record