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

NCT ID: NCT00031837

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-12-31

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.

Conditions

Pancreatic Cancer; Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dalteparin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Interventions

dalteparin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gary Morrow

OTHER

Sponsor Role: lead

Responsible Party

Gary Morrow

Director, URCC CCOP Research Base

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kishan J. Pandya, MD

Role: STUDY_CHAIR

University of Rochester

Locations

MBCCOP - Gulf Coast

Mobile, Alabama, United States

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, United States

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, United States

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Kansas City

Kansas City, Missouri, United States

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

University of Rochester Cancer Center CCOP Research Base

Rochester, New York, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

CCOP - Columbus

Columbus, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Northwest

Tacoma, Washington, United States

Countries

United States

Other Identifiers

URCC-U2200

Identifier Type: -

Identifier Source: secondary_id

NCI-5012

Identifier Type: -

Identifier Source: secondary_id

NCI-CCC-99-45

Identifier Type: -

Identifier Source: secondary_id

NCI-P02-0212

Identifier Type: -

Identifier Source: secondary_id

CDR0000069232

Identifier Type: -

Identifier Source: org_study_id