A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
18 Years
N/A
Both
Pancreatic Cancer, Thromboembolism
Trial Information
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
OBJECTIVES:
Primary
- Compare the incidence of venous thromboembolism in patients with locally advanced or
metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin
versus gemcitabine hydrochloride alone.
Secondary
- Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12
weeks, of patients treated with these regimens.
- Compare the toxicity of these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to disease progression in patients treated with these regimens.
- Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers
of thromboangiogenesis.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80%
vs < 80%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in
weeks 1-7 and 9-11.
- Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in
weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I.
Blood samples are acquired at baseline for analysis of circulating tissue factor and
vascular endothelial growth factor.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Incidence of venous thromboembolism reduction
Safety Issue:
No
Principal Investigator
Anthony Maraveyas
Investigator Role:
Study Chair
Investigator Affiliation:
Hull and East Yorkshire Hospitals NHS Trust
Authority:
Unspecified
Study ID:
CDR0000540180
NCT ID:
NCT00462852
Start Date:
April 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Thromboembolism
- thromboembolism
- stage III pancreatic cancer
- stage IV pancreatic cancer
- adenocarcinoma of the pancreas
- recurrent pancreatic cancer
- stage II pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
- Thromboembolism
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