Combination Chemotherapy for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191815
First received: September 12, 2005
Last updated: November 9, 2009
Last verified: November 2009

September 12, 2005
November 9, 2009
October 2002
Not Provided
Objective Tumor Response [ Time Frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.) ] [ Designated as safety issue: No ]
objective tumor response rate (ORR)
Complete list of historical versions of study NCT00191815 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Time to Progressive Disease [ Time Frame: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Survival Time [ Time Frame: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ] [ Designated as safety issue: Yes ]
  • Number of Deaths [ Time Frame: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Adverse Events Leading to Discontinuation [ Time Frame: Baseline through eight 21-day cycles ] [ Designated as safety issue: Yes ]
  • duration of response
  • time to progressive disease
  • time to treatment failure
  • survival time
  • txicity of GC combination
Not Provided
Not Provided
 
Combination Chemotherapy for Metastatic Breast Cancer
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Gemcitabine
    Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
  • Drug: cisplatin
    Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
Experimental: Gemcitabine + Cisplatin
Interventions:
  • Drug: Gemcitabine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2007
Not Provided

Inclusion Criteria:

  • You are female in the age of 18 to 75 years old.
  • You have been diagnosed with the metastatic breast cancer.
  • You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
  • You must sign this informed consent form

Exclusion Criteria:

  • You are pregnant or breastfeeding.
  • Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
  • You have been diagnosed with serious concomitant or acute infectious disease.
  • You have used experimental medications within the last month.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Russian Federation
 
NCT00191815
7311, B9E-VI-S326
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Eli Lilly and Company
November 2009

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