Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072865
• Other study ID #: 7771
• Secondary ID: H3E-MW-JMGJ
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2003
• Last updated: January 24, 2007
• Start date: June 2003
• Est. completion date: September 2005

Study information

• Verified date: January 2007
• 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

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer

• No prior chemotherapy for locally advanced or metastatic breast disease.

• Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.

• Adequate bone marrow, liver and kidney function

• RECIST criteria for disease status

Exclusion Criteria:

• Prior treatment with pemetrexed

• Pregnant or breast feeding

• Brain Metastasis

• unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

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
• Neoplasm Metastasis

Intervention

Drug:
• Pemetrexed

• Carboplatin

Locations

Country	Name	City	State
Russian Federation	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician	Moscow	Russia
Russian Federation	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician	Saint Petersburg	Russia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antitumor activity
Secondary	duration of response;time to progressive disease;time to treatment failure