Pancreatic Cancer Research

Clinical trialPhase 2Terminated

Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer

Phase II Trial of Docetaxel and Liposomal Doxorubicin (Doxil) Chemotherapy Combined With Enoxaparin in Patients With Advanced Pancreatic Cancer

Outcome
Stopped earlyInadequate number of eligible patients (Enrollment)
Phase
Phase 2
Status
Terminated
Study type
Interventional
Start
November 2006
Expected end
August 2009
Enrollment
2 participants
Sites
1
Primary outcomes
Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy
Sponsor
Other
Results posted
2017-06-02
Last update
29 December 2017

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to assess the effects of the treatment combination of the commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood thinner Enoxaparin on 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.

Detailed description public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy [9 weeks]. Count Of Participants, Participants. Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin (n=1): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle [3 weeks]. Number, Blood draw. Incidences within normal range D-Dimer <.50: Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin (n=2): 3. Incidence with elevated D-Dimer >.50: Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin (n=2): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle [3 weeks].