Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

March 13, 2013 updated by: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-70 years old
  • Resistant to enthracycle and taxanes
  • Has measurable disease

Exclusion Criteria:

  • Has more than 3 previous chemotherapy regimens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PC Regimen
Drug: pemetrexed plus cisplatin
pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression
Other Names:
  • Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS (progression free survival)
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 2 years
2 years
Safety
Time Frame: 2 years
Assessing for Hematology and Non-hematology toxicities, including all SAEs.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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