Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer
Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer
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.
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 </= 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.