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

Pancreatic Cancer Clinical Trial

Official title:

A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00031837
• Other study ID #: CDR0000069232
• Secondary ID: URCC-U2200NCI-50
• Status: Terminated
• Phase: Phase 3
• First received: March 8, 2002
• Last updated: October 13, 2015
• Start date: October 2002
• Est. completion date: December 2006

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Thromboembolism

Intervention

Drug:
• dalteparin

• gemcitabine hydrochloride

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	University of Rochester Cancer Center CCOP Research Base	Rochester	New York
United States	CCOP - Northwest	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as measured by FACT-Hep version 4 every 4 weeks			No
Secondary	Survival			No
Secondary	Frequency of symptomatic venous thromboembolic complications			No
Secondary	Safety as measured by the occurrence of bleeding complications			Yes