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A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer
This study has been completed.
First Received: January 25, 2005   Last Updated: November 28, 2007   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00102219
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Pemetrexed
Drug: Doxorubicin
 Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Pemetrexed Pemetrexed disodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate

Secondary Outcome Measures:
  • Time to progressive disease
  • Progression-free survival
  • Overall survival

Enrollment: 77
Study Start Date: October 2004
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102219

Locations
Brazil
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
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
Sao Paulo, Brazil
Brazil, BH
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
Greece
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
Hungary
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
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
Szekesfehervar, Hungary
Peru
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
Poland
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
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
Spain
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
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
Venezuela
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 8426, H3E-MC-JMGV
Study First Received: January 25, 2005
Last Updated: November 28, 2007
ClinicalTrials.gov Identifier: NCT00102219     History of Changes
Health Authority: United States: Food and Drug Administration;   Poland: Ministry of Health

Study placed in the following topic categories:
Antimetabolites
Folic Acid
Pemetrexed
Anti-Bacterial Agents
Skin Diseases
 Breast Neoplasms
Folic Acid Antagonists
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors
Folic Acid Antagonists
 Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions
Pemetrexed
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009



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