This phase 3 trial is examining the effectiveness of a combination treatment with panitumumab (Vectibix), leucovorin and fluorouracil after chemotherapy combined with panitumumab in metastatic (spread to other parts of the body) colorectal cancer.
The main outcome to be measured is progression-free survival (PFS; time from treatment to cancer growing or spreading) and tumor response. This study is being conducted in the US, in California.
The details
Chemotherapy is a combination of drugs that kill tumor cells, stopping them from dividing or spreading. Targeted therapy such as panitumumab also affects tumor cells by stopping them from growing and spreading. The combination of both treatments may be beneficial for patients with inoperable colorectal cancer.
This study will examine the effectiveness of combined chemotherapy with panitumumab followed by maintenance treatment (treatment meant to keep cancer from coming back) with panitumumab, leucovorin, and fluorouracil. The main outcomes to be measured are PFS and tumor response by comparing tumor size before and after treatment.
Who are they looking for?
This study is looking to recruit 450 participants with advanced colorectal cancer that cannot be removed by surgery. Patients must not have received chemotherapy before or within 6 months of starting the treatment. Female patients must not be pregnant. Participants must have normal magnesium blood levels, normal blood cell counts and normal liver and kidney function tests.
Patients will be excluded if they have brain metastasis, lung disease or HIV. Patients must not have had radiation therapy within 2 weeks of the study or other cancers in the past 3 years.
How will it work
All patients will receive panitumumab by injection into the vein over 30 to 60 minutes, oxaliplatin over 2 hours, and leucovorin and fluorouracil over 46 to 48 hours on day 1. Treatment repeats every 14 days for up to 6 cycles. Patients who are still inoperable, who do not have cancer growth or do not have disappearance of the tumors will be randomly assigned into one of two groups for maintenance treatment.
One group will receive panitumumab by injection over 30 minutes, leucovorin and fluorouracil over 46 to 48 hours on day 1. The treatment repeats every 14 days until disease progression or side effects. The second group will receive oral capecitabine twice a day on days 1 to 21. Treatment repeats every 21 days until progression or side effects. After the treatment, patients will be followed-up every 3 months.
PFS will be determined by comparing tumor size before, during and after therapy.
