Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the
rectum (end of the colon). Several drugs are often given in combination to treat colorectal
cancer. One of the most active treatment combinations is known as FOLFOX, which is a
combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of
platinum drug and was approved by the FDA in 2004. While generally well-tolerated,
oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity.
Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical
studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No
significant nerve toxicity has been seen in previous studies of picoplatin.
This study will review the safety and effectiveness of FOLPI, which is the combination of
5-FU and leucovorin with picoplatin in participants with colorectal cancer.