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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Zhang rong, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01667211
First received: July 10, 2012
Last updated: August 21, 2012
Last verified: August 2012

July 10, 2012
August 21, 2012
November 2011
December 2014   (final data collection date for primary outcome measure)
response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
Percentage of patients who achieve PR/CR based on RECIST
Complete list of historical versions of study NCT01667211 on ClinicalTrials.gov Archive Site
  • Time to progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measure of time from study treatment to disease progression
  • 2-year progression-free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Percentage of patients who have PFS two years after receiving study treatment.
  • safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Percentage of patients who experience an adverse event during this study.
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Measure of time from study treatment to patient's death or lost to follow-up.
  • Time to progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measure of time from study treatment to disease progression
  • 2-year progression-free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Percentage of patients who have PFS two years after receiving study treatment.
  • safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Percentage of patients who experience an adverse event during this study.
  • OS [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Measure of time from study treatment to patient's death or lost to follow-up.
Not Provided
Not Provided
 
Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer
A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer

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

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
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Cervical Cancer
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)
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.
Intervention: Drug: albumin-bound paclitaxel plus nedaplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2016
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cervical cancer, advanced or recurrent metastasis
  • Measurable and assessible tumor lesions
  • Used ordinary paclitaxel or platinum drugs, more than 28 days
  • Aged 18-70
  • KPS score> 60 points, expected to survive more than 3 months
  • Normal bone marrow function
  • The function of liver and kidney had no obvious damage
  • Normal function of vital organs
  • No brain metastases
  • Patients or their agents to sign informed consent
  • Compliance, and can be followed up regularly

Exclusion Criteria:

  • Brain metastases
  • Serious complications
  • Acute inflammatory response
  • Combined with other tumor
  • Pregnancy or breast-feeding women
  • Vertebral metastasis with nerve compression symptoms
  • Large volume of pleural effusion, pericardial effusion
  • Other malignancy within five years
  • Drug allergy
  • Other chemotherapy contraindications
  • The possibility of pregnancy, and not willing to contraception
  • No measurement of lesion
  • Mental illness which is difficult to control
Female
18 Years to 70 Years
Yes
Contact: Rong Zhang 008613911982343 super0078888@sina.com
China
 
NCT01667211
CH-GYN-001, 11-92/527
No
Zhang rong, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Rong Zhang Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP