Clinical trial · Interventional
Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalteparin | Drug | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of venous thromboembolism reduction
Secondary outcomes (5)
- measure
- Early survival benefit
- measure
- Toxicity
- measure
- Overall survival
- measure
- Time to disease progression
- measure
- Effect of drug combination on serological markers of thromboangiogenesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5. PMID 33337539
- DERIVEDMaraveyas A, Waters J, Roy R, Fyfe D, Propper D, Lofts F, Sgouros J, Gardiner E, Wedgwood K, Ettelaie C, Bozas G. Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. Eur J Cancer. 2012 Jun;48(9):1283-92. doi: 10.1016/j.ejca.2011.10.017. Epub 2011 Nov 17. PMID 22100906