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A Trial to Evaluate Epothilone D in Patients with Advanced Solid Tumors



A Trial to Evaluate Epothilone D in Patients with Advanced Solid Tumors

For Condition: Neoplasms
Status: Completed
Sponsor(s): Kosan Biosciences ,
Synopsis: Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1.Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas. 2.Evidence of radiographically measurable or evaluable disease. Exclusion Criteria: 1.Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause. 2.Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.
Total Enrollment: 45

Location and Contact Information:

Overall Study Official:
LeeRosen,  Principal Investigator,  UCLA Division of Hematology-Oncology

UCLA Medical Center
Los Angeles,  California,  90095-7059
United States
 


Additional Information:
Study ID Numbers:
  KOS-101; 
Study Start Date: October 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030173

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