Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00097383
First received: November 22, 2004
Last updated: July 18, 2006
Last verified: July 2006
  Purpose

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin 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.


Condition Intervention Phase
Breast Cancer
Drug: ALIMTA plus Epirubicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

  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 not amenable to local treatment.
  • Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
  • Patients must have at least one measurable lesion in an area not previously irradiated.
  • No chemotherapy at least 4 weeks prior to study enrollment.
  • Signed informed consent from patient.

Exclusion Criteria:

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious systemic disorders, including active infection.
  • Significant cardiovascular disease.
  • Pregnancy or breast feeding.
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097383

Locations
Argentina
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
La Plata, Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Buenos Aires, Argentina
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Ciudad De Buenos Aires, Argentina
Belgium
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Brussels, Belgium
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Leuven, Belgium
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Wilrijk, Belgium
Brazil
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Maceio, AL, Brazil
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Belo Horizonte, BH, Brazil
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Curitiba, PR, Brazil
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Porto Alegre, RS, Brazil
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Sao Paulo, Sao Paulo/SP, Brazil
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Sao Paulo, SP, Brazil
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Sorocaba, SP, Brazil
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Sao Paulo, Brazil
Mexico
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Guadalajara, Jalisco, Mexico
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Mexico, Mexico D.F., Mexico
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Col. Campestre Churubusco, Mexico
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Mexico City, Mexico
Portugal
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Arquiparque-Miraflores, Alges, Portugal
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Coimbra, Portugal
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Lisboa, Portugal
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Porto, Portugal
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Proto, Portugal
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Santa Maria Da Feira, Portugal
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Santarem, Portugal
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00097383     History of Changes
Other Study ID Numbers: 4028, H3E-MC-JMDU
Study First Received: November 22, 2004
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014