A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

January 24, 2007 updated by: Eli Lilly and Company

A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine regimen when given to patients with metastatic breast cancer. Each agent has well demonstrated antitumor activity in patients with locally advanced or metastatic breast cancer. In addition, in the phase I combination trial of the two agents, a durable tumor response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al. 2000). Therefore, it is reasonable to expect that the combination of pemetrexed and gemcitabine administered may be associated with considerably more anti-tumor activity than either agent alone. If such activity is seen in this study, randomized studies comparing this combination with other active agents or combinations of active agents will be considered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

INCLUSION:

  1. Have a performance status of 0 to 2 on the ECOG performance status schedule.
  2. Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
  3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
  4. Have adequate organ function including the following

EXCLUSION:

1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)

Secondary Outcome Measures

Outcome Measure
To measure time-to-event efficacy variables including: time to objective tumor response for responding patients, duration of response for responding pts, time to treatment failure, time to progressive disease, progression free survival, overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours,EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 26, 2007

Last Update Submitted That Met QC Criteria

January 24, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9305
  • H3E-CA-S050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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