Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer - Full Text View

Purpose

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

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

ChemIDplus related topics:

Gemcitabine hydrochloride Gemcitabine Paclitaxel Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-Adjuvant/Adjuvant Chemotherapy With Anthracycline

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:

Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Median survival and 1 and 2 year survival [ Time Frame: baseline to date of death from any cause, evaluated at 1 year and 2 years ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: cycle 1, day 1 and 8 ] [ Designated as safety issue: Yes ]

Enrollment:	62
Study Start Date:	June 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: gemcitabine Phase 1: 1000 mg/m2, IV, day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1 Drug: paclitaxel Phase 1: 175 mg/m2, IV, q 21 days x 2 cycles Phase 2: 175 mg/m2, IV, q 21 days x 2 cycles

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically and/or cytologically confirmed breast cancer
Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
To have at least one measurable region
ECOG Performance Status: 0-1
To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

To have interstitial pneumonia or pulmonary fibrosis
To have inflammatory breast cancer
Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
To have brain metastases with symptoms
To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334802

Locations


Japan
	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.
	Ehime, Japan, 790-0007
	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.
	Tokyo, Japan, 104-8560
	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.
	Fukuoka, Japan, 814-0180
	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.
	Shizuoka, Japan, 430-8558
	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.
	Kanagawa, Japan, 259-1193
	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.
	Chiba, Japan, 296-8602
	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.
	Hiroshima, Japan, 737-0023
	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.
	Hokkaido, Japan, 060-0006
	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.
	Kumamoto, Japan, 862-8505
	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.
	Iwate, Japan, 020-8505
	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.
	Aichi, Japan, 464-8681
	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.
	Gunma, Japan, 373-8550
	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.
	Saitama, Japan, 338-8553
	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.
	Osaka, Japan, 590-0064
	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.
	Kagoshima, Japan, 892-0833

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

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9066, B9E-JE-MB22
First Received:	June 6, 2006
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00334802
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Skin Diseases

Guaifenesin

Phenylephrine

Paclitaxel

Breast Neoplasms

Phenylpropanolamine

Gemcitabine

Breast Diseases

Recurrence

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 October 14, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00334802