A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191672
• Other study ID #: 6966
• Secondary ID: B9E-US-S308
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: December 2003
• Est. completion date: November 2006

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

The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced or metastatic breast cancer

• Disease that can be measured by the physician or radiologic test.

• May have had one chemotherapy treatment for advanced or metastatic disease.

• Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment.

• Patients may have received prior hormone therapy or immunotherapy.

Exclusion Criteria:

• Patients with only non-measurable disease

• Cancer that has spread to the brain

• A patient who received a taxane with metastatic disease.

• Pregnancy

• Patients who received prior gemcitabine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Gemcitabine

• Paclitaxel

• Docetaxel

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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Katy	Texas
United States	For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nashville	Tennessee

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	Estimate the response rate of two regimens separately.
Secondary	Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status
Secondary	Nature of toxicities experienced on each arm of the study