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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Gary Morrow | National Cancer Institute (NCI) |
United States,
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 |
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