NCT02935309

Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma

Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rectal Cancer
• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-14
• Primary completion: 2019-10-11
• Completion: 2020-05-14
• First posted: 2016-10-17
• Last updated: 2022-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study