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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00191672

Collaborator

(none)

120

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Gemcitabine Drug: Paclitaxel Drug: Docetaxel	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2003

Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

Estimate the response rate of two regimens separately. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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	United States
2	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

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