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A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00191984
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : June 15, 2009
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE April 27, 2009
Results First Posted Date  ICMJE June 15, 2009
Last Update Posted Date January 5, 2011
Study Start Date  ICMJE June 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years follow-up) ]
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. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Assessment of anti tumor activity measured by tumor response rate analyzed at the end of the study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
  • Duration of Response [ Time Frame: time of response to progressive disease or death (up to 2 years follow-up) ]
    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
  • Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease or death (up to 2 years follow-up) ]
    Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.
  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 2 years follow-up) ]
    Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
  • Overall Survival [ Time Frame: baseline to date of death from any cause (up to 2 years follow-up) ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Duration of response for responding patients, progression free survival, time to treatment failure, overall survival and toxicity assessed at the end of the study (every 3 months up to 24 months after treatment discontinuation)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
Official Title  ICMJE Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks
Brief Summary A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
    Other Names:
    • LY231514
    • Alimta
  • Drug: irinotecan
    180 mg/m^2, intravenous (IV), every 14 days x 12 cycles
Study Arms  ICMJE Experimental: Pemetrexed + Irinotecan
Interventions:
  • Drug: pemetrexed
  • Drug: irinotecan
Publications * Louvet C, André T, Gamelin E, Hebbar M, Mabro M, Bennamoun M, Rassam H, de Gramont A. Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer. J Oncol. 2010;2010:785934. doi: 10.1155/2010/785934. Epub 2010 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
46
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
45
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
  • Patient must have at least one unidimensionally measurable lesion.
  • Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
  • Performance status 0 to 2
  • Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease

Exclusion Criteria:

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious systemic disorder (cardiac or pulmonary disease, active infection)
  • Documented brain metastases not amenable to surgery or unstable after radiation
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
  • Presence of fluid retention that can not be controlled by drainage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00191984
Other Study ID Numbers  ICMJE 8673
H3E-FP-S057 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP