Status:
COMPLETED
Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Conditions:
Pancreatic Cancer
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, suc...
Detailed Description
OBJECTIVES: Primary * Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus g...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas
- Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
- Measurable or evaluable disease
- No clinical evidence of active venous thromboembolism
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
- Life expectancy \> 12 weeks
- Absolute neutrophil count \> 2,000/mm³
- WBC \> 3,000/mm³
- Platelet count \> 100,000/mm³
- Creatinine clearance \> 50 mL/min
- INR ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN (stent allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No cerebrovascular accident within the past 6 months
- No obvious contraindication to anticoagulation, including the following:
- Bleeding diathesis
- Active peptic ulcer
- Ulcerating cancer into duodenum
- No history of other advanced malignancy
- No gross hematuria
- No melaena or gross evidence of gastrointestinal bleeding (other than piles)
- No requirement for a central line
- No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation
- PRIOR CONCURRENT THERAPY:
- No prior gemcitabine hydrochloride-containing treatment
- No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
- No other concurrent specific anticancer therapy as a result of disease progression
- No concurrent caval filter device
- No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
- No concurrent acetylsalicylic acid (\> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
- No concurrent clopidogrel bisulfate
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00462852
Start Date
April 1 2003
End Date
November 1 2011
Last Update
August 12 2013
Active Locations (8)
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1
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
2
Royal Lancaster Infirmary
Lancaster, England, United Kingdom, LA1 4RP
3
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
4
St. George's Hospital
London, England, United Kingdom, SW17 0QT