Taxoprexin® Treatment for Advanced Primary Cancers of the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422877
Recruitment Status : Terminated (Sponsor suspended development of the drug on September 3, 2008.)
First Posted : January 17, 2007
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Cancer of the Liver Drug: Taxoprexin Phase 2

Detailed Description:
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with advanced primary cancers of the liver, including hepatocellular carcinoma (HCC), or carcinoma of the gallbladder or biliary tract (BTC), who have not received prior systemic cytotoxic therapy for advanced disease. Patients may have previously received radiation and/or systemic chemotherapy as adjuvant therapy. Patients may not have been treated previously with a taxane. Patients may have been previously treated with up to two immunological and/or biologic agents (e.g., interferon, monoclonal antibodies, tyrosine kinase inhibitors). Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 (400mg/m2 for patients with an elevated bilirubin at baseline) intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Second Line Therapy for Patients With Advanced Primary Cancers of the Liver, Including Hepatocellular Carcinoma and Carcinoma of the Gallbladder or Biliary Tract
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Taxoprexin
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

Primary Outcome Measures :
  1. Response Rate

Secondary Outcome Measures :
  1. Time to progression
  2. Time to treatment failure
  3. Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients must have at least one measurable lesion by RECIST criteria.
  3. 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.
  4. At least 6 weeks (42 days) since any prior immunologic or biologic therapy.
  5. At least 4 weeks (28 days) since prior radiotherapy to >20% of the bone marrow or prior adjuvant chemotherapy.
  6. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
  7. Patients must have ECOG performance status of 0-2.
  8. Patients must be at least 18 years of age.
  9. Patients must have adequate liver and renal function.
  10. Patients must have adequate bone marrow function.
  11. 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.

Exclusion Criteria:

  1. Patients who have received prior therapy with any taxane.
  2. 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.
  3. Patients with symptomatic brain metastasis (es).
  4. 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.
  5. Patients with active infections currently receiving anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
  6. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
  7. Patients with unstable or serious concurrent medical conditions are excluded.
  8. Patients with a known hypersensitivity to Cremophor®.
  9. 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, CNS metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
  10. Patients with a history of Gilbert's Syndrome.
  11. Patients must not receive any concurrent chemotherapy, radiotherapy, non-FDA approved nutritional supplements or herbal preparations or immunotherapy while on study.
  12. Known HIV disease or infection.
  13. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine or diltiazem.
  14. Patients must not have had any surgical procedure requiring hospitalization and administration of general anesthesia within the past 28 days.
  15. Patients must not have received prior systemic chemotherapy for advanced disease. Prior adjuvant systematic chemotherapy (non-taxane containing) is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422877

United States, Texas
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Luitpold Pharmaceuticals
Study Director: Ahmed Kaseb, M.D. M.D. Anderson Cancer Center

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00422877     History of Changes
Other Study ID Numbers: P01-05-23
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Luitpold Pharmaceuticals:
Liver Cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action