Pemetrexed and Carboplatin in Locally Advanced or Metasta... | NCT00072865

Studies
Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

NCT00072865

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Jan 26, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Breast Cancer
Neoplasm Metastasis

Interventions

Pemetrexed
Carboplatin

Countries

Russia

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

ID	Type	Description	Link
H3E-MW-JMGJ

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Nov 12, 2003

First Submission Date that Met QC Criteria

Nov 12, 2003

First Posted Date

Nov 13, 2003Estimated

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

Jan 24, 2007

Last Update Posted Date

Jan 26, 2007Estimated

Description Module

Brief Summary

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
antitumor activity

Measure	Description	Time Frame
duration of response;time to progressive disease;time to treatment failure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
No prior chemotherapy for locally advanced or metastatic breast disease.
Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
Adequate bone marrow, liver and kidney function
RECIST criteria for disease status

Exclusion Criteria:

Prior treatment with pemetrexed
Pregnant or breast feeding
Brain Metastasis
unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician		Moscow	Russia		Russia

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068437	Pemetrexed
D016190	Carboplatin

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Pemetrexed	Drug
Carboplatin	Drug