A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
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