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
  Purpose

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


Condition Intervention Phase
Uterine Cervical Cancer
Drug: albumin-bound paclitaxel plus nedaplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667211

Contacts
Contact: Rong Zhang 008613911982343 super0078888@sina.com

Locations
China
Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology Recruiting
Beijing, China, 100021
Contact: Rong Zhang    008613911982343    super0078888@sina.com   
Principal Investigator: Rong Zhang         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Rong Zhang Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Zhang rong, Chief Physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01667211     History of Changes
Other Study ID Numbers: CH-GYN-001, 11-92/527
Study First Received: July 10, 2012
Last Updated: August 21, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Advanced uterine cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Nedaplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014