This phase 1/2 trial is examining the effectiveness of liposomal irinotecan (LI; Onivyde) and rucaparib (Rubraca) in treating patients with advanced colorectal cancer. The main outcome to be measured will be the toxicity and tumor response to the treatment. This trial is being conducted in Arizona, Georgia, Minnesota, and Utah, US.
Drugs used in chemotherapy such as LI and rucaparib work in different ways to stop the growth of tumor cells. Some drugs kill the tumor, others stop them from dividing or from spreading. Chemotherapy usually consists of a combination of these drugs. Combining drugs might improve the effectiveness of the treatment which can decrease drug resistance. However, often at the expense of a higher toxicity. The effectiveness and toxicity of this combined treatment against different advanced cancers is still not clear.
This trial is examining the effectiveness of LI and rucaparib given together with fluorouracil (Efudex) and leucovorin calcium (folinic acid) in patients with advanced colorectal cancer. The main outcome will be measured by the number of patients with mild to severe toxicities and tumor response by measuring tumor size before and after treatment.
Who are they looking for?
This trial is recruiting 110 patients with advanced colorectal cancer and other advanced cancers of the digestive system who progressed after first-line treatment. Patients must have normal blood levels and must be on contraception during treatment and for 6 months after treatment.
Patients must not be pregnant or breastfeeding or have a severe condition. Must not have an immune disease, an active infection or receiving any other experimental drug. Must not have received treatment for another tumor within 3 years before this trial.
How will it work
Patients will receive treatment with LI (by injection) over 90 minutes, leucovorincalcium and fluorouracil over 46 hours on days 1 and 15. They will also receive rucaparib (tablets) twice daily on days 4 to 13 and 18 to 27. Therapy courses will repeat every 28 days until disease progression or toxicity. Patients will be followed for 3 years after the treatment.