Docetaxel And Liposomal Doxorubicin Chemotherapy With Enoxaparin In Patients With Advanced Pancreatic Cancer

Study Overview

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.

Pancreatic Cancer

DRUG: Docetaxel
DRUG: Liposomal Doxorubicin
DRUG: Enoxaparin

200511721

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-01-23	Results First Submitted 2017-03-01	Last Update Submitted that met QC Criteria 2017-12-05
First Submitted that Met QC Criteria 2007-01-23	Results First Submitted that Met QC Criteria 2017-04-26	Last Update Posted (ACTUAL) 2017-12-29
First Posted (ACTUAL) 2007-01-24	Results First Posted 2017-06-02	Last Verified 2017-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 DRUG: Liposomal Doxorubicin DRUG: Enoxaparin

Participant Group/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

DRUG: Liposomal Doxorubicin

DRUG: Enoxaparin

Primary Outcome Measures	Measure Description	Time Frame
Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy		9 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle	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.	3 weeks
Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle		3 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Aventis Pharmaceuticals

Investigators

PRINCIPAL_INVESTIGATOR: Daniel J. Berg, MD, University of Iowa

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record