Trial of Pemetrexed in Combined With Cisplatin for the Tr... | NCT01143974

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

NCT01143974

Sponsor

Chinese Academy of Medical Sciences

Status

Completed

Last Update Posted

Mar 14, 2013Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Locally Advanced Malignant Neoplasm

Interventions

pemetrexed plus cisplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2013

Last Update Posted Date

Mar 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peng Yuan, Associate chief physician, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PC Regimen	Experimental		Drug: pemetrexed plus cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed plus cisplatin	Drug	pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression	PC Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS (progression free survival)		2 Years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Has more than 3 previous chemotherapy regimens

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Binghe Xu, M.D.	Chinese Academy of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Institute & Hospital. Chinese Academy of Medical Sciences		Beijing		100021	China

Intervention Browse Module

MeSH Terms

ID	Term
D000068437	Pemetrexed
D002945	Cisplatin

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided