- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36607
- MBCCOP - Gulf Coast
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Colorado
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Denver, Colorado, United States, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Michigan
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Missouri
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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New York
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East Syracuse, New York, United States, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center CCOP Research Base
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North Carolina
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Goldsboro, North Carolina, United States, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Columbus, Ohio, United States, 43215
- CCOP - Columbus
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Dayton, Ohio, United States, 45429
- CCOP - Dayton
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South Carolina
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Washington
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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 rest for each subsequent cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Quality of life as measured by FACT-Hep version 4 every 4 weeks
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Secondary Outcome Measures
Outcome Measure |
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Survival
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Frequency of symptomatic venous thromboembolic complications
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Safety as measured by the occurrence of bleeding complications
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kishan J. Pandya, MD, University of Rochester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Embolism and Thrombosis
- Pancreatic Diseases
- Pancreatic Neoplasms
- Thromboembolism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anticoagulants
- Gemcitabine
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- CDR0000069232
- URCC-U2200
- NCI-5012
- NCI-CCC-99-45
- NCI-P02-0212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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