NCT01667211

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

3.1 years

First QC Date

July 10, 2012

Last Update Submit

August 21, 2012

Conditions

Uterine Cervical Cancer

Keywords

Advanced uterine cervical cancer

Outcome Measures

Primary Outcomes (1)

  • response rate

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

    one year

Secondary Outcomes (4)

  • Time to progression (TTP)

    2 years

  • 2-year progression-free survival (PFS)

    2 years

  • safety and tolerability

    2 years

  • Overall survival (OS)

    5 years

Study Arms (1)

albumin-bound paclitaxel plus nedaplatin

EXPERIMENTAL

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

Interventions

albumin-bound paclitaxel plus nedaplatinDRUG

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.

Also known as: Abraxane (albumin-bound paclitaxel)
albumin-bound paclitaxel plus nedaplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Albumin-Bound Paclitaxelnedaplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Rong Zhang

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Zhang

CONTACT

008613911982343super0078888@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

July 10, 2012

First Posted

August 17, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

CN(1)