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

This study has been terminated.
(Inadequate number of eligible patients)
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00426127
First received: January 23, 2007
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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
Pancreatic Cancer
Drug: Docetaxel
Drug: Liposomal Doxorubicin
Drug: Enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Tumor response measured by CT scans after cycles 3 and 6

Secondary Outcome Measures:
  • Incidence of elevated D-Dimer measured by drawing D-Dimer levels every cycle
  • Safety and effect of chemo regimen on D-Dimer measured by drawing D-Dimer levels every cycle

Estimated Enrollment: 27
Study Start Date: November 2006
Study Completion Date: January 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426127

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Aventis Pharmaceuticals
Investigators
Principal Investigator: Daniel J. Berg, MD University of Iowa
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel J. Berg, MD Associate Professor Internal Medicine, University of Iowa Hospitals and CLinics
ClinicalTrials.gov Identifier: NCT00426127     History of Changes
Other Study ID Numbers: UIEnox001
Study First Received: January 23, 2007
Last Updated: March 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Pancreatic
Docetaxel
Doxorubicin
Enoxaparin

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Doxorubicin
Docetaxel
Enoxaparin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014