Clinical trial NCT00031837: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatic Cancer
Thromboembolism
Keywords: thromboembolism
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life as measured by FACT-Hep version 4 every 4 weeks
Secondary outcomes:
measure: Survival
measure: Frequency of symptomatic venous thromboembolic complications
measure: Safety as measured by the occurrence of bleeding complications
Other outcomes:
Locations:
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Denver
country: United States
facility: CCOP - Colorado Cancer Research Program, Incorporated
state: Colorado
city: Chicago
country: United States
facility: MBCCOP - University of Illinois at Chicago
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center CCOP Research Base
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
Study officials:
affiliation: University of Rochester
name: Kishan J. Pandya, MD
role: STUDY_CHAIR
References: