Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract

NCT00422877 | Terminated Phase 2

• 1 other identifier: P01-05-23
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with primary liver cancer being treated with weekly Taxoprexin® Injection. To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.

Conditions

Cancer of the Liver

Keywords

Liver cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR)

  Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.

  Assessed every 6 weeks, up to 12 months

Secondary Outcomes (3)

• Time to progression (TTP)

  Up to 12 months

• Time to Treatment Failure (TTF)

  Baseline to stopping treatment

• Overall Participant Survival

  Up to 12 months

Study Arms (1)

Taxoprexin

EXPERIMENTAL

Starting dose of 500 mg/m2 (400 mg/m2 for patients with an elevated bilirubin at baseline) administered intravenously by a 1-hour infusion weekly for the first 5 weeks of a 6 week cycle.

Drug: Taxoprexin

Interventions

Taxoprexin DRUG

Administered by intravenous infusion over 1 hour infusion

Also known as: Docosahexaenoic acid (DHA)-paclitaxel

Taxoprexin

Eligibility Criteria

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

You may qualify if:

• Patients must have histologic or cytologic confirmation of primary cancer of the liver, including HCC or adenocarcinoma of the gallbladder or bile ducts and advanced (unresectable and/or metastatic) disease.
• Patients must have at least one measurable lesion by RECIST criteria.
• Patients may have received up to two prior systemic non-cytotoxic regimens for their disease. Prior treatment with immunologic and/or biologic agents is allowed.
• At least 6 weeks (42 days) since any prior immunologic or biologic therapy.
• At least 4 weeks (28 days) since prior radiotherapy to \>20% of the bone marrow or prior adjuvant chemotherapy.
• Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Patients must be at least 18 years of age.
• Patients must have adequate liver and renal function.
• Patients must have adequate bone marrow function.
• Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

You may not qualify if:

• Patients who have received prior therapy with any taxane.
• Patients who have a past or current history of cancer other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
• Patients with symptomatic brain metastasis (es).
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
• Patients with active infections currently receiving anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
• Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
• Patients with unstable or serious concurrent medical conditions are excluded.
• Patients with a known hypersensitivity to Cremophor®.
• Patients with one or more of the following as the only manifestations of disease are ineligible: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, central nervous system (CNS) metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
• Patients with a history of Gilbert's Syndrome.
• Patients must not receive any concurrent chemotherapy, radiotherapy, non-FDA approved nutritional supplements or herbal preparations or immunotherapy while on study.
• Known HIV disease or infection.
• Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine or diltiazem.
• Patients must not have had any surgical procedure requiring hospitalization and administration of general anesthesia within the past 28 days.
• Patients must not have received prior systemic chemotherapy for advanced disease. Prior adjuvant systematic chemotherapy (non-taxane containing) is allowed.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

docosahexaenoyl-paclitaxel; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ahmed Kaseb, M.D.

  M.D. Anderson Cancer Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 16, 2025

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)