Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract (NCT00422877) | Clinical Trial Compass
TerminatedPhase 2
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
Stopped: Sponsor suspended development of the drug on September 3, 2008.
United States13 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. 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.
âś“. Patients must have at least one measurable lesion by RECIST criteria.
âś“. 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.
âś“. At least 6 weeks (42 days) since any prior immunologic or biologic therapy.
âś“. At least 4 weeks (28 days) since prior radiotherapy to \>20% of the bone marrow or prior adjuvant chemotherapy.
âś“. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
âś“. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
âś“. Patients must be at least 18 years of age.
Exclusion criteria
What they're measuring
1
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR)
Timeframe: Assessed every 6 weeks, up to 12 months
. Patients who have received prior therapy with any taxane.
âś•. 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.
âś•. Patients with symptomatic brain metastasis (es).
âś•. 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.
âś•. Patients with active infections currently receiving anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
âś•. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
âś•. Patients with unstable or serious concurrent medical conditions are excluded.
✕. Patients with a known hypersensitivity to Cremophor®.