Phase II Trial of Docetaxel and Liposomal Doxorubicin (Doxil) Chemotherapy Combined With Enoxaparin in Patients With Advanced Pancreatic Cancer
The objective of the study is to determine the safety and efficacy of the combination of
docetaxel and liposomal doxorubicin chemotherapy combined with enoxaparin in patients with
advanced pancreatic cancer.
Docetaxel (TAXOTERE) belongs to the group of anticancer drugs called mitotic inhibitors.
Liposomal doxorubicin (Doxil) is an anthracycline, and is thought to prevent nucleic acid
synthesis that is needed to make DNA. Enoxaparin (Lovenox) is an anticoagulant. We are
interested in combining chemotherapy with the blood thinner enoxaparin because there is a
scientific link between blood clotting and malignancy.
This research is being done to improve on currently available chemotherapy treatments for
advanced pancreatic cancer. The main goal of the study is to find out if this combination
chemotherapy and enoxaparin increases the number of individuals whose tumors shrink. Another
purpose of this study is to find out how this study treatment effects blood clotting levels
in individuals. We will also determine the incidence of elevated D-dimer and the effect of
this regimen on the level of D-dimer, and collect safety data on this regimen.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response measured by CT scans after cycles 3 and 6
Daniel J. Berg, MD
University of Iowa
United States: Institutional Review Board
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|