Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGPemetrexed
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| to assess the following time to event efficacy endpoints for patients in both treatment arms: | — |
| overall survival | — |
| The secondary objectives of the study are as follows: | — |
| duration of response | — |
| to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population | — |
| progression free survival | — |
Countries
Australia, Germany, Greece, Netherlands, Spain
Outcome results
None listed