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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

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.

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 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
- Stable neurological status without clinical evidence of CNS metastases and/or stroke.
Peripheral neuropathy must be
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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response measured by CT scans after cycles 3 and 6

Principal Investigator

Daniel J. Berg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

January 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic
  • Docetaxel
  • Doxorubicin
  • Enoxaparin
  • Pancreatic Neoplasms



University of Iowa Hospitals and Clinics Iowa City, Iowa  52242