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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: pemetrexed; Drug: irinotecan

• Registration Number: NCT00191984
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-02
• Study Completion: 2008-05
• Results First Submitted: 2009-04-27
• Results First Submitted QC: 2009-04-27
• Results First Posted: 2009-06-15
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-03
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemetrexed + Irinotecan	irinotecan	-
Pemetrexed + Irinotecan	pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Best Overall Tumor Response	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	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)	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	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	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.

Trial Locations

Locations (1)

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, France