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Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00106002
Recruitment Status : Completed
First Posted : March 21, 2005
Results First Posted : June 1, 2009
Last Update Posted : June 1, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Neoplasms, Male Carcinoma, Ductal Drug: pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
Study Start Date : April 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: pemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Other Names:
  • LY231514
  • Alimta


Outcome Measures
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Primary Outcome Measures :
  1. Overall Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
    Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.


Secondary Outcome Measures :
  1. Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) [ Time Frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up ]
    Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).

  2. Duration of Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
    Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.

  3. Progression-Free Survival Time [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
    Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

  4. Overall Survival Time [ Time Frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up ]
    Defined as the time from date of first dose to time of death due to any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have been diagnosed with either advanced or metastatic breast cancer.
  • Chemotherapy has not been given for advanced or metastatic breast cancer.
  • The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
  • Able to carry out work of a light nature (for example, light housework, office work).
  • Must be at least 18 years old.

Exclusion Criteria:

  • Have received prior bone marrow or peripheral stem cell transplantation.
  • Have received prior chemotherapy for metastatic breast cancer.
  • Are currently pregnant or breast-feeding.
  • Have an active infection that your doctor decides will affect your safety.
  • Are unable to take folic acid or vitamin B12.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106002


Locations
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United States, Texas
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.
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Additional Information:

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00106002    
Other Study ID Numbers: 9028
H3E-US-S045
First Posted: March 21, 2005    Key Record Dates
Results First Posted: June 1, 2009
Last Update Posted: June 1, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors