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

Phase 2CompletedNCT00191984

Eli Lilly and Company46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

pemetrexedDRUG

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

irinotecanDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Lille, France

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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

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.

Data from ClinicalTrials.gov

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