Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer (CSAPPPCC)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667211
|Contact: Rong Zhangfirstname.lastname@example.org|
|Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology||Recruiting|
|Beijing, China, 100021|
|Contact: Rong Zhang 008613911982343 email@example.com|
|Principal Investigator: Rong Zhang|
|Principal Investigator:||Rong Zhang||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|