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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191347
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: pemetrexed
Drug: gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 30
Study Start Date: October 2004
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191347

Locations
Canada, Ontario
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.
Ottawa, Ontario, Canada
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00191347     History of Changes
Other Study ID Numbers: 9305, H3E-CA-S050
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 22, 2013