This trial is examining the effectiveness and toxicity of COTI-2 treatment in patients with advanced cancer. The main outcomes to be measured will be cancer response to the treatment and number of side effects. This study is being conducted in Texas, US.
The details
Cancer resistance to therapy affects successful cancer treatment. The standard treatment to overcome resistance is the combination of more than one agent. However, this is associated with higher toxicity rates. New drugs such as COTI-2 are less likely to cause treatment resistance. COTI-2 is an experimental treatment that works by repairing a defective gene. Therefore, the use of this agent might improve anti-tumor activity with less associated toxicity.
This trial is evaluating the effectiveness of COTI-2 in advanced tumors such as colorectal cancer. The main outcome will be the tumor response to the treatment which will be measured through CT scanning.
Who are they looking for?
This trial is recruiting 51 participants with colorectal cancer and other advanced tumors. Participants must have a cancer that is recurrent (it came back after treatment), metastatic (spread to other parts of the body) or inoperable. Patients must have a life expectancy of 3 months or more and normal blood tests. Patients who are capable of becoming pregnant must use effective contraception.
Patients must have stopped prior treatment at least 28 days before the start of the trial and all toxicities resolved. Patients must not be pregnant or breastfeeding, have any severe conditions or any active infection. These patients must not have received any major surgery within the 28 days prior to the trial.
How will it work
Patients will be divided into 2 groups. One group will receive COTI-2 alone and the other will also receive cisplatin (Platinol). Participants will receive different doses of COTI-2, in tablets, once daily for 5 days followed by 2 treatment-free days.
Patients will be evaluated up to 12 months to determine side effects, clinical response and survival without cancer growing or spreading.
