A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
Data Collection
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan. The purposes of this study are to determine: * How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy. * The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan. * Whether pemetrexed can help patients with colorectal cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: The patient must have: * Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum. * Performance status of 0 to 2 on the ECOG Performance Status Scale. * Standard postoperative adjuvant radiation therapy for rectal cancer is allowed. * Locally advanced or metastatic disease. * Must be 18 years of age. Exclusion Criteria: The patient must not have: * Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment. * Received prior treatment with irinotecan in the adjuvant setting. * Are unable to take vitamin B12 or folic acid. * Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period. * Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
NSW, QLD, South Australia, AustraliaSee the locationFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Woodville, AustraliaFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Frankfurt/Main, GermanyFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Krete, Greece