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

Primary Purpose

Uterine Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
albumin-bound paclitaxel plus nedaplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Cancer focused on measuring Advanced uterine cervical cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

albumin-bound paclitaxel plus nedaplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

response rate
Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST

Secondary Outcome Measures

Time to progression (TTP)
Measure of time from study treatment to disease progression
2-year progression-free survival (PFS)
Percentage of patients who have PFS two years after receiving study treatment.
safety and tolerability
Percentage of patients who experience an adverse event during this study.
Overall survival (OS)
Measure of time from study treatment to patient's death or lost to follow-up.

Full Information

First Posted
July 10, 2012
Last Updated
August 21, 2012
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01667211
Brief Title
Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer
Acronym
CSAPPPCC
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer
Keywords
Advanced uterine cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
albumin-bound paclitaxel plus nedaplatin
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
albumin-bound paclitaxel plus nedaplatin
Other Intervention Name(s)
Abraxane (albumin-bound paclitaxel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
response rate
Description
Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
Time Frame
one year
Secondary Outcome Measure Information:
Title
Time to progression (TTP)
Description
Measure of time from study treatment to disease progression
Time Frame
2 years
Title
2-year progression-free survival (PFS)
Description
Percentage of patients who have PFS two years after receiving study treatment.
Time Frame
2 years
Title
safety and tolerability
Description
Percentage of patients who experience an adverse event during this study.
Time Frame
2 years
Title
Overall survival (OS)
Description
Measure of time from study treatment to patient's death or lost to follow-up.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Zhang
Phone
008613911982343
Email
super0078888@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Zhang
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Zhang
Phone
008613911982343
Email
super0078888@sina.com
First Name & Middle Initial & Last Name & Degree
Rong Zhang

12. IPD Sharing Statement

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

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