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Sponsors and Collaborators: |
University of Iowa Aventis Pharmaceuticals |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00426127 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Docetaxel Drug: Liposomal Doxorubicin Drug: Enoxaparin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Docetaxel and Liposomal Doxorubicin (Doxil) Chemotherapy Combined With Enoxaparin in Patients With Advanced Pancreatic Cancer |
Estimated Enrollment: | 27 |
Study Start Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel J. Berg, MD | 319-353-7800 | daniel-berg@uiowa.edu |
Contact: Pamela Zehr, RN | 319-353-8914 | pamela-zehr@uiowa.edu |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Daniel J. Berg, MD | University of Iowa |
Study ID Numbers: | UIEnox001 |
Study First Received: | January 23, 2007 |
Last Updated: | January 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00426127 |
Health Authority: | United States: Institutional Review Board |
Pancreatic Docetaxel Doxorubicin Enoxaparin |
Docetaxel Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Doxorubicin Enoxaparin Endocrine Gland Neoplasms |
Fibrin Modulating Agents Neoplasms Anticoagulants Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Antibiotics, Antineoplastic Pharmacologic Actions |