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

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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
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Daniel Berg, University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Docetaxel Drug: Liposomal Doxorubicin Drug: Enoxaparin Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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
Primary Completion Date : January 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin
Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Drug: Docetaxel
Other Name: Taxotere
Drug: Liposomal Doxorubicin
Other Name: caelyx
Drug: Enoxaparin
Other Name: Lovenox

Primary Outcome Measures :
  1. Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically-confirmed pancreatic carcinoma, with at least one lesion measurable by CT scan with a longest diameter of > 10mm, (other than bone) that has either not been previously irradiated, or if previously irradiated, has demonstrated progression since the radiation therapy based on RECIST criteria.
  • Locally-advanced unresectable disease or be ineligible for neo-adjuvant therapy (Stage III disease, unresectable and medically unfit for neo-adjuvant treatment or decline chemo radiation treatment) or have metastatic disease.
  • 18 years of age or greater. Female patients with child-bearing potential must have a negative pregnancy test at screening. All patients of reproductive potential must agree to practice effective contraception in order to participate in this study for duration of treatment and for 3 months post.
  • WBC >3000 cells/mm3 with segments over 1800, hemoglobin >10 g/dl, platelets >150,000 cells/mm3, creatinine <1.5 mg/dl.
  • Hepatic function: Total Bilirubin </= ULN. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
  • ECOG performance status of </= 2 and an expected survival of at least 3 months.
  • Stable neurological status without clinical evidence of CNS metastases and/or stroke. Peripheral neuropathy must be </= Grade 1.

Exclusion Criteria:

  • Chemotherapy or radiation therapy within the preceding 4 weeks. Patients must never have had docetaxel or liposomal or regular doxorubicin.
  • Spinal/epidural anesthesia and/or catheters for pain management
  • New York Heart Association (NYHA) class III or IV congestive heart failure
  • Evidence of duodenal erosion from the cancer.
  • Heparin or coumadin at the time of enrollment, with the exception of low dose coumadin (1 mg/day or less) administered prophylactically and/or heparin for maintenance of in-dwelling lines or ports.
  • Acute DVT or PE on initial evaluation
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • Pregnant or breast feeding
  • Undergone a major surgical procedure, open biopsy, or major traumatic injury less than 4 weeks prior to study entry. Fine needle aspirations or venous access devices are allowed if placed > 7 days before study treatment begins.
  • Presence of active or suspected acute or chronic uncontrolled infection, including abscess or fistula
  • HIV positive
  • History of another malignancy within 5 years prior to study entry, except curatively treated basal cell skin cancer or cervical cancer in situ
  • Medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
  • Enoxaparin is contraindicated in patients with active major bleeding or who are at high risk for bleeding, in patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium, or in patients with hypersensitivity to enoxaparin sodium. Patients with known hypersensitivity to heparin or pork products should not be treated with enoxaparin injection or any of its constituents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
University of Iowa
Aventis Pharmaceuticals
Principal Investigator: Daniel J. Berg, MD University of Iowa

Additional Information:
Responsible Party: Daniel Berg, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00426127     History of Changes
Other Study ID Numbers: 200511721
First Posted: January 24, 2007    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Berg, University of Iowa:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liposomal doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors