A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
Data Collection
Breast Diseases+5
+ Breast Neoplasms
+ Neoplasm Metastasis
Treatment Study
Summary
Study start date: June 1, 2003
Actual date on which the first participant was enrolled.This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer * No prior chemotherapy for locally advanced or metastatic breast disease. * Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment. * Adequate bone marrow, liver and kidney function * RECIST criteria for disease status Exclusion Criteria: * Prior treatment with pemetrexed * Pregnant or breast feeding * Brain Metastasis * unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Moscow, Russian FederationSee the locationFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Saint Petersburg, Russian Federation