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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:

Study Description
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

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
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :
  1. Overall Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]

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 ]
  2. Duration of Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
  3. Progression-Free Survival Time [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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
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:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00106002     History of Changes
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:
Breast Neoplasms, Male
Breast Neoplasms
Carcinoma, Ductal
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