Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 ]

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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

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
Results First Posted:	June 1, 2009
Last Update Posted:	June 1, 2009
Last Verified:	April 2009

Additional relevant MeSH terms:

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