Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer

Eli Lilly and Company120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Colorectal Cancer

Interventions

PemetrexedDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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, Victoria, Australia

Outcomes

Primary Outcomes

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 Outcomes

The secondary objectives of the study are as follows:

to assess the following time to event efficacy endpoints for patients in both treatment arms:

overall survival

progression free survival

duration of response

to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population

Data from ClinicalTrials.gov

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