Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: gemcitabine; Drug: paclitaxel

• Registration Number: NCT00334802
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-08
• Primary Completion: 2008-02
• Results First Submitted: 2009-05-29
• Results First Submitted QC: 2009-05-29
• Results First Posted: 2009-07-20
• Status Verified: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-10
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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
• Eastern Cooperative Oncology Group (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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	paclitaxel	-
A	gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Tumor Response	baseline to measured progressive disease	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	time of response to progressive disease	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time to Progressive Disease	baseline to measured progressive disease	Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Number of Participants Alive at One Year (1-Year Survival)	baseline to date of death from any cause, evaluated at 1 year
Pharmacokinetics - Maximum Plasma Concentration (Cmax)	cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)	Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.
Pharmacokinetics - Area Under the Concentration Curve (AUC)	cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)	Area under the concentration curve from time zero to infinity.
Pharmacokinetics - Half Life (t½)	cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)	Apparent elimination half-life.

Trial Locations

Locations (1)

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