This trial is comparing the effectiveness and toxicity of ABT-165 or bevacizumab (Avastin) plus FOLFIRI (irinotecan, leucovorin, fluorouracil) chemotherapy in patients with metastatic (spread to other parts of the body) colorectal cancer.
The main outcome to be measured will be tumor response and survival without cancer worsening.
Colorectal cancer is the third most common cancer in the US. The standard treatment is chemotherapy and surgery. However, chemotherapy has only a limited effectiveness. The treatment of these patients often includes other targeted therapy agents such as ABT-165 and bevacizumab to improve the effectiveness of the treatment. It is still not clear how these agents can help the treatment of advanced colorectal cancer patients.
This study will compare the effectiveness of ABT-165 or bevacizumab added to FOLFIRI chemotherapy in patients with metastatic colorectal cancer. Survival without cancer worsening will be the main outcome.
Who are they looking for?
This trial is recruiting 100 participants. Patients should have had surgery more than 3 months prior to the start of this trial, tumor progression after first-line treatment with chemotherapy, and adequate blood cell counts and liver and kidney function tests.
Patients should not have had any treatment with irinotecan, should not have active toxicities from prior cancer treatment or any active major disease.
How will it work
Patients will be assigned to receive ABT-165 plus FOLFIRI or bevacizumab plus FOLFIRI. Progression-free survival (time from treatment to disease progression) and tumor response rate will be measured up to 2 years.