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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

pemetrexed

irinotecan

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed + Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Full Information

NCT ID

NCT00191984

First Posted

September 12, 2005

Last Updated

January 3, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00191984

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed + Irinotecan

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

400 mg/m^2, intravenous (IV), every 14 days x 12 cycles

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Description

180 mg/m^2, intravenous (IV), every 14 days x 12 cycles

Primary Outcome Measure Information:

Title

Best Overall Tumor Response

Description

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.

Time Frame

baseline to measured progressive disease (up to 2 years follow-up)

Secondary Outcome Measure Information:

Title

Duration of Response

Description

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 Frame

time of response to progressive disease or death (up to 2 years follow-up)

Title

Progression-Free Survival (PFS)

Description

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 Frame

baseline to measured progressive disease or death (up to 2 years follow-up)

Title

Time to Treatment Failure

Description

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.

Time Frame

baseline to stopping treatment (up to 2 years follow-up)

Title

Overall Survival

Description

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time Frame

baseline to date of death from any cause (up to 2 years follow-up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name