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Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063570
First Posted: July 1, 2003
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.

Condition Intervention Phase
Breast Cancer Breast Neoplasms Drug: Pemetrexed Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

Secondary Outcome Measures:
  • Duration of (Confirmed) Complete Response or Partial Response [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]
  • Time to Progressive Disease [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]
  • Time to Treatment Failure [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]
  • Overall Survival [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

Enrollment: 73
Study Start Date: July 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 14 days, until disease progression
Other Name: LY231514, Alimta
Drug: Gemcitabine
1500 mg/m2, intravenous (IV), every 14 days, until disease progression
Other Name: LY188011, Gemzar
Experimental: B Drug: Gemcitabine
1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
Other Names:
  • LY188011
  • Gemzar
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
  • LY231514
  • Alimta

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
  • Less than 3 different chemotherapy treatments for metastatic disease.
  • Prior treatment with hormonal and/or radiation therapy.
  • Must have disease that can be measured.
  • Must be able to take care of self needs for example personal hygiene

Exclusion Criteria:

  • Must not be pregnant or breast-feeding.
  • Cancer that has spread to the brain.
  • Treatment with Gemcitabine or Pemetrexed
  • Unable to take folic acid or Vitamin B12
  • Treatment for another cancer within the last 5 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063570


Locations
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Aurora, Colorado, United States
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Plantation, Florida, United States
United States, North Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Morrisville, North Carolina, United States
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Philadelphia, Pennsylvania, United States
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Dallas, Texas, United States
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Seattle, Washington, United States
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
San Juan, Puerto Rico
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00063570     History of Changes
Other Study ID Numbers: 5141
H3E-US-JMEO
First Submitted: June 30, 2003
First Posted: July 1, 2003
Results First Submitted: January 27, 2009
Results First Posted: May 13, 2009
Last Update Posted: July 29, 2009
Last Verified: May 2009

Keywords provided by Eli Lilly and Company:
Cancer of Breast
Cancer of the Breast

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