Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer (PAM07)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.
PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.
Chemotherapeutic Agent Toxicity
Drug: Chemotherapy at the investigator's discretion
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas|
- Thromboembolic events [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]number of thromboembolic events during anticoagulation treatment
- Progression-free survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: at one year ] [ Designated as safety issue: No ]
- Tolerance of regimens [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: chemotherapy
chemotherapy at investigator's discretion
|Drug: Chemotherapy at the investigator's discretion|
dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
|Drug: daltéparine Drug: Chemotherapy at the investigator's discretion|
- To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events.
- To determine the number of thromboembolic events occurring with preventive anticoagulation.
- To determine survival without thrombotic event.
- To determine progression-free and overall survival.
- To determine time to response of tumor.
- To assess tolerance of these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment arms.
- Arm A: Patients receive chemotherapy at investigator's discretion
- Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all arms, treatment repeats in the absence of disease progression or unacceptable toxicity.
Blood and plasma samples are obtained at baseline and periodically during study. Blood is examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor, mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are assessed in plasma.
After completion of study therapy, patients are followed periodically.
|Centre Hospitalier de Meaux|
|Meaux, France, 77104|
|Centre Hospitalier Intercommunal Le Raincy - Montfermeil|
|Montfermeil, France, 93370|
|Paris, France, 75651|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Suresnes, France, 92151|
|Principal Investigator:||Benoist Chibauldel, MD||Hopital Saint Antoine|