Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00106002
First received: March 18, 2005
Last updated: May 29, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Breast Cancer
Breast Neoplasms, Male
Carcinoma, Ductal
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Duration of Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ] [ Designated as safety issue: No ]
  • Progression-Free Survival Time [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: April 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Other Names:
  • LY231514
  • Alimta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00106002     History of Changes
Other Study ID Numbers: 9028, H3E-US-S045
Study First Received: March 18, 2005
Results First Received: December 23, 2008
Last Updated: May 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Carcinoma
Breast Neoplasms, Male
Carcinoma, Ductal
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 28, 2014