- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00106002
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
May 29, 2009 updated by: Eli Lilly and Company
A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer.
The collection of DNA is optional to the patient.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
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
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Texas
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Dallas, Texas, United States, 75204
- For additional information regarding investigative sites for this 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.
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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
All
Description
Inclusion Criteria:
- Must have been diagnosed with either advanced or metastatic breast cancer.
- Chemotherapy has not been given for advanced or metastatic breast cancer.
- The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
- Able to carry out work of a light nature (for example, light housework, office work).
- Must be at least 18 years old.
Exclusion Criteria:
- Have received prior bone marrow or peripheral stem cell transplantation.
- Have received prior chemotherapy for metastatic breast cancer.
- Are currently pregnant or breast-feeding.
- Have an active infection that your doctor decides will affect your safety.
- Are unable to take folic acid or vitamin B12.
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
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600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Tumor Response
Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Time Frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
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Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
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every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
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Duration of Tumor Response
Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Progression-Free Survival Time
Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Overall Survival Time
Time Frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
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Defined as the time from date of first dose to time of death due to any cause.
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every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 18, 2005
First Submitted That Met QC Criteria
March 18, 2005
First Posted (Estimate)
March 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 1, 2009
Last Update Submitted That Met QC Criteria
May 29, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Breast Neoplasms
- Breast Neoplasms, Male
- Carcinoma, Ductal
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- 9028
- H3E-US-S045
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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PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
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University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
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Ain Shams UniversityUnknown
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GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom