Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer (CSAPPPCC)
|ClinicalTrials.gov Identifier: NCT01667211|
Recruitment Status : Unknown
Verified August 2012 by Zhang rong, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : August 17, 2012
Last Update Posted : August 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Cancer||Drug: albumin-bound paclitaxel plus nedaplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
Experimental: albumin-bound paclitaxel plus nedaplatin
albumin-bound paclitaxel plus nedaplatin: Intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
Drug: albumin-bound paclitaxel plus nedaplatin
intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
Other Name: Abraxane (albumin-bound paclitaxel)
- response rate [ Time Frame: one year ]Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
- Time to progression (TTP) [ Time Frame: 2 years ]Measure of time from study treatment to disease progression
- 2-year progression-free survival (PFS) [ Time Frame: 2 years ]Percentage of patients who have PFS two years after receiving study treatment.
- safety and tolerability [ Time Frame: 2 years ]Percentage of patients who experience an adverse event during this study.
- Overall survival (OS) [ Time Frame: 5 years ]Measure of time from study treatment to patient's death or lost to follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667211
|Contact: Rong Zhangemail@example.com|
|Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology||Recruiting|
|Beijing, China, 100021|
|Contact: Rong Zhang 008613911982343 firstname.lastname@example.org|
|Principal Investigator: Rong Zhang|
|Principal Investigator:||Rong Zhang||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|