Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

Eli Lilly and Company1 site in 1 country70 target enrollmentOctober 2002

ConditionsBreast Cancer

InterventionsGemcitabine cisplatin

DrugsGemcitabine cisplatin

Overview

Phase: Phase 2
Intervention: Gemcitabine
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Enrollment: 70
Locations: 1
Primary Endpoint: Objective Tumor Response
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

October 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Eli Lilly and Company

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.

Arms & Interventions

Gemcitabine + Cisplatin

Intervention: Gemcitabine

Gemcitabine + Cisplatin

Intervention: cisplatin

Outcomes

Primary Outcomes

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.)

Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcomes

Duration of Response(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.))
Time to Progressive Disease(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.))
Time to Treatment Failure(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.))
Survival Time(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.))
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination(Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy))
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades(Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy))
Number of Deaths(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.))
Number of Participants With Adverse Events Leading to Discontinuation(Baseline through eight 21-day cycles)