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

Sponsor

Gary Morrow (Other)

Overall Status

Terminated

CT.gov ID

NCT00031837

Collaborator

National Cancer Institute (NCI) (NIH)

400

Enrollment

Locations

Arm

Duration (Months)

30.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Thromboembolism	Drug: dalteparin Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: dalteparin Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment

Arm

Intervention/Treatment

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.

Drug: dalteparin

Drug: gemcitabine hydrochloride

Procedure: quality-of-life assessment

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36607
2	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
3	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
4	CCOP - Central Illinois	Decatur	Illinois	United States	62526
5	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
6	CCOP - Kansas City	Kansas City	Missouri	United States	64131
7	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
8	University of Rochester Cancer Center CCOP Research Base	Rochester	New York	United States	14642
9	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
10	CCOP - Columbus	Columbus	Ohio	United States	43215
11	CCOP - Dayton	Dayton	Ohio	United States	45429
12	CCOP - Greenville	Greenville	South Carolina	United States	29615
13	CCOP - Northwest	Tacoma	Washington	United States	98405-0986