Skip to main content
OpenTrials
Completed

NCT Number: NCT00334802

Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gemcitabine

Drug

Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)

Phase 2: dose determined by phase 1

Other names: LY188011, Gemzar

paclitaxel

Drug

Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles

Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles

Primary outcomes

  1. Tumor Response

    Time frame: 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 outcomes

  1. Duration of Response

    Time frame: 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.

  2. Time to Progressive Disease

    Time frame: 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.

  3. Number of Participants Alive at One Year (1-Year Survival)

    Time frame: baseline to date of death from any cause, evaluated at 1 year

  4. Pharmacokinetics - Maximum Plasma Concentration (Cmax)

    Time frame: 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.

  5. Pharmacokinetics - Area Under the Concentration Curve (AUC)

    Time frame: 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.

  6. Pharmacokinetics - Half Life (t½)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jun 8, 2006
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.