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

Metastatic Colorectal Cancer Clinical Trial

Official title:

Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191984
• Other study ID #: 8673
• Secondary ID: H3E-FP-S057
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 3, 2011
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• pemetrexed
400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
• irinotecan
180 mg/m^2, intravenous (IV), every 14 days x 12 cycles

Locations

Country	Name	City	State
France	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.	Angers
France	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.	Lille
France	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.	Montfermeil
France	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.	Paris
France	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.	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best 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.; 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.	baseline to measured progressive disease (up to 2 years follow-up)	No
Secondary	Duration of Response	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.	time of response to progressive disease or death (up to 2 years follow-up)	No
Secondary	Progression-Free Survival (PFS)	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.	baseline to measured progressive disease or death (up to 2 years follow-up)	No
Secondary	Time to Treatment Failure	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.	baseline to stopping treatment (up to 2 years follow-up)	Yes
Secondary	Overall Survival	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.	baseline to date of death from any cause (up to 2 years follow-up)	Yes

External Links

•   Lilly Clinical Trial Registry