A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer
Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of
paclitaxel designed to avoid problems associated with solvents used in Taxol. And
albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,
and with greater concentration in tumor tissue compared with normal tissues. This is a
single center, non-randomized, open-label Phase II clinical study to investigate the
efficacy and tolerability of albumin-bound paclitaxel plus nedaplatin in patients with
advanced, recurrent metastatic cervical cancer. About 30 patients will receive 175-200
mg/m2 albumin-bound paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3
weeks. At least 2 cycles will be completed for each patient, for whom responded to the
treatment, 4-6 cycles will be completed.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate
Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
one year
No
Rong Zhang
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration
CH-GYN-001
NCT01667211
November 2011
December 2016
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