Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00426127|
Recruitment Status : Terminated (Inadequate number of eligible patients)
First Posted : January 24, 2007
Results First Posted : June 2, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Docetaxel Drug: Liposomal Doxorubicin Drug: Enoxaparin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Docetaxel and Liposomal Doxorubicin (Doxil) Chemotherapy Combined With Enoxaparin in Patients With Advanced Pancreatic Cancer|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin
Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Other Name: TaxotereDrug: Liposomal Doxorubicin
Other Name: caelyxDrug: Enoxaparin
Other Name: Lovenox
- Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy [ Time Frame: 9 weeks ]
- Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle [ Time Frame: 3 weeks ]Incidence of elevated D-Dimer was defined as >.50 as drawn every cycle. Incidence of elevated D-Dimer was tested to determine safety and efficacy of the treatment regimen on patients with advanced pancreatic cancer.
- Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle [ Time Frame: 3 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426127
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Daniel J. Berg, MD||University of Iowa|