Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 14, 2016

Primary Completion Date

October 11, 2019

Study Completion Date

May 14, 2020

Conditions
Rectal CancerRectal Adenocarcinoma
Interventions
DRUG

Lenvatinib

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.

DRUG

Capecitabine

Pre-surgery Capecitabine, 850 mg/m\^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.

RADIATION

External Radiation Therapy (XRT)

Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02935309 - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma | Biotech Hunter | Biotech Hunter