NCT01143974

Brief Summary

For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective drug for advanced breast cancer. The combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

June 14, 2010

Last Update Submit

March 13, 2013

Conditions

Locally Advanced Malignant Neoplasm

Keywords

progress free survivalresponse ratesafety

Outcome Measures

Primary Outcomes (1)

  • PFS (progression free survival)

    2 Years

Secondary Outcomes (2)

  • Safety

    2 years

  • Response Rate

    2 years

Study Arms (1)

PC Regimen

EXPERIMENTAL
Drug: pemetrexed plus cisplatin

Interventions

pemetrexed plus cisplatinDRUG

pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression

Also known as: Alimta
PC Regimen

Eligibility Criteria

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

You may qualify if:

  • years old
  • Resistant to enthracycle and taxanes
  • Has measurable disease

You may not qualify if:

  • Has more than 3 previous chemotherapy regimens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Interventions

PemetrexedCisplatin

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Binghe Xu, M.D.

    Chinese Academy of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

CN(1)