Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00031837

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer Thromboembolism	Drug: dalteparin Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Quality of life as measured by FACT-Hep version 4 every 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Designated as safety issue: No ]
Frequency of symptomatic venous thromboembolic complications [ Designated as safety issue: No ]
Safety as measured by the occurrence of bleeding complications [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC 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
AST 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031837

Locations

United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
University of Rochester Cancer Center CCOP Research Base
Rochester, New York, United States, 14642
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

Study Chair:

Kishan J. Pandya, MD

University of Rochester

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069232, URCC-U2200, NCI-5012, NCI-CCC-99-45, NCI-P02-0212
Study First Received:	March 8, 2002
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00031837 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

thromboembolism
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Thromboembolism
Fibrin Modulating Agents
Neoplasms by Site
Therapeutic Uses
Cardiovascular Diseases

Gemcitabine
Endocrine Gland Neoplasms
Anticoagulants
Digestive System Neoplasms
Vascular Diseases
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antiviral Agents
Immunosuppressive Agents
Thrombosis
Pharmacologic Actions
Embolism and Thrombosis
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on November 27, 2009