Taxoprexin® Treatment for Advanced Primary Cancers of the Liver

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00422877
First received: January 15, 2007
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Cancer of the Liver
Drug: Taxoprexin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Response Rate

Secondary Outcome Measures:
  • Time to progression
  • Time to treatment failure
  • Survival

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422877

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

No publications provided

ClinicalTrials.gov Identifier: NCT00422877     History of Changes
Other Study ID Numbers: P01-05-23
Study First Received: January 15, 2007
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Liver Cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014