Viewing Study NCT00470249



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Last Modification Date: 2024-10-26 @ 9:32 AM
Study NCT ID: NCT00470249
Status: TERMINATED
Last Update Posted: 2021-02-01
First Post: 2007-05-03

Brief Title: Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor: University of Southampton
Organization: University of Southampton

Study Overview

Official Title: A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines Taxanes
Status: TERMINATED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Due to difficulty in recruitment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Drugs used in chemotherapy such as carboplatin and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells

PURPOSE This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer
Detailed Description: OBJECTIVES

Primary

Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride

Secondary

Determine the overall toxicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the time to disease progression in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen

OUTLINE This is a nonrandomized open-label study

Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2 Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity

After completion of study therapy patients are followed periodically for 2 years

PROJECTED ACCRUAL A total of 35 patients will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2005-005164-83 EUDRACT_NUMBER None None