Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00106002|
Recruitment Status : Completed
First Posted : March 21, 2005
Results First Posted : June 1, 2009
Last Update Posted : June 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Neoplasms, Male Carcinoma, Ductal||Drug: pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
- Overall Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]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.
- 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 ]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 [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]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 [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]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 [ Time Frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up ]Defined as the time from date of first dose to time of death due to any cause.
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): NCT00106002
|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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|Dallas, Texas, United States, 75204|
|Study Director:||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)||Eli Lilly and Company|