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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00063570
First received: June 30, 2003
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00063570     History of Changes
Other Study ID Numbers: 5141, H3E-US-JMEO
Study First Received: June 30, 2003
Results First Received: January 27, 2009
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
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 June 13, 2013