This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pre-surgery Lenvatinib, days 1 - 5. Dose Escalation Levels: 1.) 10 mg by mouth (PO) daily (QD); 2.) 14 mg PO QD; 3.) 20 mg PO QD; 4.) 24 PO QD.
Pre-surgery Capecitabine, 850 mg/m\^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.
Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Maximum Tolerated Dose (MTD)
MTD of lenvatinib used in combination with capecitabine and external beam radiation as neoadjuvant therapy for patients with locally advanced rectal carcinoma. The MTD of lenvatinib will be defined as the highest dose level at which no more than 1 out of 6 participants experiences dose-limiting toxicity (DLT). DLT: Any of the hematology or non-hematologic toxicities noted in Table 3 of the protocol, considered to be at least possibly related to lenvatinib and/or capecitabine.
Time frame: Up to 6 months
Rate of Pathologic Response
Pathologic response rate after pre-operative therapy and surgery. Pathologic Complete Response (pCR) will be defined as pathologic proof of a complete response based on histologic evaluation of the resected specimen.
Time frame: Up to 36 months
Occurrence of Treatment Related Adverse Events
To further define safety profile of the combination. Adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
Time frame: Up to 36 months
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