Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106002
• Other study ID #: 9028
• Secondary ID: H3E-US-S045
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2005
• Last updated: May 29, 2009
• Start date: April 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Neoplasms, Male
• Carcinoma, Ductal

Intervention

Drug:
• pemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Tumor Response		every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	No
Secondary	Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)		every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up	Yes
Secondary	Duration of Tumor Response		every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	No
Secondary	Progression-Free Survival Time		every 3 cycles (approximately 6-7 weeks) or until patient has disease progression	No
Secondary	Overall Survival Time		every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up	Yes

External Links

•   Lilly Clinical Trial Registry