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

• 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: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 19, 2005
• Results First Submitted Date: April 27, 2009
• Results First Posted Date: June 15, 2009
• Last Update Posted Date: January 5, 2011
• Study Start Date: June 2004
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 12, 2005): Assessment of anti tumor activity measured by tumor response rate analyzed at the end of the study

Current Secondary Outcome Measures (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 (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: A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Colorectal Cancer

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2007): 46
• Original Enrollment (submitted: September 12, 2005): 45
• Actual Study Completion Date: May 2008
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00191984
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Chief Medical Officer, Eli Lilly
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• 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