A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191672

Purpose

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	Intervention	Phase
Breast Neoplasms	Drug: Gemcitabine Drug: Paclitaxel Drug: Docetaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer

Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment:	120
Study Start Date:	December 2003
Estimated Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191672

Locations

United States, Tennessee
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
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 - 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

More Information

Study ID Numbers:	6966, B9E-US-S308
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00191672
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Paclitaxel

Breast Neoplasms
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009