Back to resultsPemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Primary Purpose
Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Overall Tumor Response
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.
Secondary Outcome Measures
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
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).
Duration of Tumor Response
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.
Progression-Free Survival Time
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Overall Survival Time
Defined as the time from date of first dose to time of death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106002
Brief Title
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Official Title
A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Primary Outcome Measure Information:
Title
Overall Tumor Response
Description
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.
Time Frame
every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Secondary Outcome Measure Information:
Title
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Description
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).
Time Frame
every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
Title
Duration of Tumor Response
Description
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.
Time Frame
every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Title
Progression-Free Survival Time
Description
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time Frame
every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Title
Overall Survival Time
Description
Defined as the time from date of first dose to time of death due to any cause.
Time Frame
every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
12. IPD Sharing Statement
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Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
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