Status:
TERMINATED
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
Lead Sponsor:
American Regent, Inc.
Conditions:
Cancer of the Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00422877
Start Date
January 1 2007
End Date
March 1 2008
Last Update
October 16 2025
Active Locations (1)
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1
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030