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

Primary Purpose

Pancreatic Cancer, Thromboembolism

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
dalteparin
gemcitabine hydrochloride
quality-of-life assessment
Sponsored by
Gary Morrow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring thromboembolism, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MBCCOP - Gulf Coast
  • CCOP - Colorado Cancer Research Program, Incorporated
  • MBCCOP - University of Illinois at Chicago
  • CCOP - Central Illinois
  • CCOP - Kalamazoo
  • CCOP - Kansas City
  • CCOP - Hematology-Oncology Associates of Central New York
  • University of Rochester Cancer Center CCOP Research Base
  • CCOP - Southeast Cancer Control Consortium
  • CCOP - Columbus
  • CCOP - Dayton
  • CCOP - Greenville
  • CCOP - Northwest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dalteparin

Arm Description

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.

Outcomes

Primary Outcome Measures

Quality of life as measured by FACT-Hep version 4 every 4 weeks

Secondary Outcome Measures

Survival
Frequency of symptomatic venous thromboembolic complications
Safety as measured by the occurrence of bleeding complications

Full Information

First Posted
March 8, 2002
Last Updated
October 13, 2015
Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031837
Brief Title
Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Official Title
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Thromboembolism
Keywords
thromboembolism, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalteparin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dalteparin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life as measured by FACT-Hep version 4 every 4 weeks
Secondary Outcome Measure Information:
Title
Survival
Title
Frequency of symptomatic venous thromboembolic complications
Title
Safety as measured by the occurrence of bleeding complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishan J. Pandya, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
University of Rochester Cancer Center CCOP Research Base
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States

12. IPD Sharing Statement

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

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