Pancreatic Cancer
Conditions
Keywords
Pancreatic, Docetaxel, Doxorubicin, Enoxaparin
Brief 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.
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.
Interventions
DRUGDocetaxel
DRUGLiposomal Doxorubicin
DRUGEnoxaparin
Sponsors
Aventis Pharmaceuticals
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy | 9 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle | 3 weeks | 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. |
| Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle | 3 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Removed due to disease progression | 1 |
Baseline characteristics
| Characteristic | Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 61.8 Years |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy
Time frame: 9 weeks
Population: One participant underwent 3 cycles of therapy and progressed as assessed by CT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin | Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy | 1 Participants |
Secondary
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.
Time frame: 3 weeks
Population: 2 patients received at least one cycle of treatment and underwent blood draws testing D-Dimer levels
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin | Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle | Incidences within normal range D-Dimer <.50 | 3 Blood draw |
| Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin | Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle | Incidence with elevated D-Dimer >.50 | 1 Blood draw |
Secondary
Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle
Time frame: 3 weeks
Population: There was no analysis done