Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of MEK162 in Combination With FOLFOX in Patients With Advanced Metastatic Colorectal Cancer Who Failed Prior Standard Therapy
This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) for the combination of MEK162 (MEK inhibitor
MEK162) plus leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX) in patients with
metastatic colorectal cancer.
SECONDARY OBJECTIVES:
I. Describe the safety of the combination of MEK162 across all investigated dose levels.
II. Describe the pharmacokinetics of MEK162 and FOLFOX in 6 patients in the expanded MTD
cohort.
III. Describe any clinical activity to the combination using Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 criteria.
IV. Determine the recommended Phase II dose (RP2D) which may be less than the MTD for both
intermittent and continuous dosing of MEK162.
OUTLINE: This is a dose-escalation study of MEK inhibitor MEK162. Patients are assigned to 1
of 2 treatment arms.
ARM I: Patients receive MEK inhibitor MEK162 orally (PO) twice daily (BID) on days 1-14, and
leucovorin calcium intravenously (IV) over 2 hours, oxaliplatin IV over 2 hours, and
fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in
the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive MEK inhibitor MEK162 PO BID on days 1-5, and leucovorin calcium IV
over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV continuously over 46 hours on
days 6 and 7. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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