Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer

NCT00426127 | Terminated Phase 2 Results DMC

• 1 other identifier: 200511721
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic; Docetaxel; Doxorubicin; Enoxaparin

Outcome Measures

Primary Outcomes (1)

• Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy

  9 weeks

Secondary Outcomes (2)

• Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle

  3 weeks

• Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle

  3 weeks

Study Arms (1)

Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin

EXPERIMENTAL

Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg

Drug: Docetaxel; Drug: Liposomal Doxorubicin; Drug: Enoxaparin

Interventions

Docetaxel DRUG

Also known as: Taxotere

Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin

Liposomal Doxorubicin DRUG

Also known as: caelyx

Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin

Enoxaparin DRUG

Also known as: Lovenox

Docetaxel and Liposomal Doxorubicin Combined with Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Links

• Website for Holden Comprehensive Cancer Center at University of Iowa

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Docetaxel; liposomal doxorubicin; Enoxaparin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Study closed early due to slow accrual. No analysis done, 2 subjects received study treatment. Both subjects went off study due to progression and complications from cancer.

Results Point of Contact

• Title: Daniel Berg, MD
• Organization: University of Iowa

daniel-j-berg@uiowa.edu

319-353-7800

Study Officials

• Daniel J. Berg, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: November 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 29, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)