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Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00334802
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : July 20, 2009
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 6, 2006
First Posted Date  ICMJE June 8, 2006
Results First Submitted Date  ICMJE May 29, 2009
Results First Posted Date  ICMJE July 20, 2009
Last Update Posted Date March 16, 2010
Study Start Date  ICMJE June 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
Response Rate
Change History Complete list of historical versions of study NCT00334802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
  • 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.
  • 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.
  • Number of Participants Alive at One Year (1-Year Survival) [ Time Frame: baseline to date of death from any cause, evaluated at 1 year ]
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
  • Time to PD
  • Overall Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Official Title  ICMJE Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: gemcitabine

    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
  • Drug: paclitaxel

    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

Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: gemcitabine
  • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
62
Original Enrollment  ICMJE
 (submitted: June 6, 2006)
61
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00334802
Other Study ID Numbers  ICMJE 9066
B9E-JE-MB22 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP