drugset / Trial / NCT00785421
Chemotherapy With or Without Enoxaparin in Pancreatic Cancer
Phase 2/3
Completed
312 enrolled
CONKO-Studiengruppe
Amgen · collabEli Lilly and Company · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm. N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%
Timeline
- Start
- 2004-04
- Primary completion
- 2009-01
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |
| Comparator | Cisplatin | Other / unclassified | 30 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1 g | — |
| Comparator | Leucovorin | Small molecule | 200 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 750 mg/m2 | — |