Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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, such as dalteparin, may help prevent blood clots from forming in patients being treated with gemcitabine for pancreatic cancer.

PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or without dalteparin in treating patients with locally advanced or metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust
• Treatments: Dalteparin; Gemcitabine; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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