Clinical trial NCT00191815: Combination Chemotherapy for Metastatic Breast Cancer
Official title: Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Tumor Response
timeFrame: 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.)
Secondary outcomes:
measure: Duration of Response
timeFrame: 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.)
measure: Time to Progressive Disease
timeFrame: 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.)
measure: Time to Treatment Failure
timeFrame: 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.)
measure: Survival Time
timeFrame: 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.)
measure: Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
timeFrame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
measure: Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
timeFrame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
measure: Number of Deaths
timeFrame: 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.)
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: Baseline through eight 21-day cycles
Other outcomes:
Locations:
city: Munich
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST),
role: STUDY_DIRECTOR
References: