Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00316199

Purpose

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: gemcitabine Drug: paclitaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment, Uncontrolled
Official Title:	Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to treatment failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Overall survival. [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	April 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: gemcitabine 1250 mg/m2, IV, day 1 and day 8 q 21 days until disease progression Drug: paclitaxel 175 mg/m2, IV, q 21 days until disease progression

Eligibility

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

Criteria

Inclusion Criteria:

Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
Unresectable, locally recurrent breast cancer or stage IV disease.
Have at least one measurable lesion as defined by RECIST criteria.
Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria:

Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Active infection or other serious condition.
Pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316199

Locations

China
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.
Beijing, China, 100071
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.
Guang Zhou, China, 510060
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.
Shanghai, China, 200032

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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9803, B9E-MC-JHST
Study First Received:	April 18, 2006
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00316199 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Radiation-Sensitizing Agents
Skin Diseases
Paclitaxel
Tubulin Modulators
Breast Neoplasms

Antimitotic Agents
Gemcitabine
Antineoplastic Agents, Phytogenic
Immunosuppressive Agents
Antiviral Agents
Breast Diseases

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on March 16, 2009