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This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.
OUTLINE: This is a multi-center study.
Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 2,000 mg orally once daily every day for 8 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.
Subjects will undergo fatigue assessments, using the MFSI-SF instrument and PROMIS. Subjects will have a pill count prior to the beginning of each cycle and will have a re-staging computerized tomography (CT) scan of chest/abdomen/pelvis at the end of cycle 2/ week 8.
The following laboratory values must be obtained within 7 days prior to registration for protocol therapy:
- Absolute neutrophil count (ANC) count > 1,500/mm3
- Hemoglobin (Hgb) > 9g/dL
- Platelet count > 100,000/mm3
- Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
- Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
- International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Not yet recruiting
Hoosier Cancer Research Network
Published on BioPortfolio: 2015-10-21T14:23:22-0400
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Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
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