Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer — CSAPPPCC  

Uterine Cervical Cancer Clinical Trial

Official title: A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer

Status Recruiting

Clinical Trial Summary

Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

• NCT number: NCT01667211
• Study type: Interventional
• Source: Chinese Academy of Medical Sciences
• Contact: Rong Zhang
• Phone: 008613911982343
• Email: super0078888@sina.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2011
• Completion date: December 2016