Clinical trial · Interventional
Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
- 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 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.
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 |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dalteparin
- description
- 5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.
- interventionNames
- Drug: dalteparin
- Drug: gemcitabine hydrochloride
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Quality of life as measured by FACT-Hep version 4 every 4 weeks
Secondary outcomes (3)
- measure
- Survival
- measure
- Frequency of symptomatic venous thromboembolic complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available