Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Docetaxel; Liposomal Doxorubicin; Enoxaparin
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin; Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic; Docetaxel; Doxorubicin; Enoxaparin

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.
    

Eligibility 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.