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A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer

NCT ID: NCT00102219

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-10-31

Brief Summary

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This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been combined with other drugs, but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs. However, there is no guarantee that the patient will benefit from this treatment.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxorubicin

Intervention Type DRUG

Pemetrexed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment.
* Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy.
* At least one measurable lesion.
* No chemotherapy within 4 weeks prior to enrollment.
* Signed informed consent from the patient.

Exclusion Criteria

* Prior chemotherapy for metastatic breast cancer.
* Prior treatment with any anthracyclines or anthracenedione-containing regimen.
* Treatment within the last 30 days with any drug that has not received regulatory approval.
* Pregnancy and/or breast feeding.
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Belo Horizonte, BH, Brazil

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

São Paulo, São Paulo, Brazil

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Rio de Janeiro, , Brazil

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Athens, , Greece

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Budapest, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Székesfehérvár, , Hungary

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Lima, , Peru

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Krakow, , Poland

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Lodz, , Poland

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Madrid, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Valencia, , Spain

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Caracas, , Venezuela

Site Status

Countries

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Brazil Greece Hungary Peru Poland Spain Venezuela

Other Identifiers

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H3E-MC-JMGV

Identifier Type: -

Identifier Source: secondary_id

8426

Identifier Type: -

Identifier Source: org_study_id