NCT00869570

External-Beam Radiation Therapy, Capecitabine, and Sorafenib in Treating Patients With Locally Advanced Rectal Cancer

Neoadjuvant Radiotherapy Combined With Capecitabine and Sorafenib in Patients With Advanced, K-ras Mutated Rectal Cancer. A Multicenter Phase I/IIa Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving radiation therapy together with capecitabine and sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with sorafenib and external-beam radiation therapy and to see how well it works in treating patients with locally advanced rectal cancer.

Detailed description

OBJECTIVES: * Determine the recommended dose of neoadjuvant capecitabine when given together with sorafenib tosylate and external-beam radiotherapy in patients with K-ras mutated, locally advanced rectal cancer. (Phase I) * Assess the efficacy and safety of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter, phase I, dose-escalation study of capecitabine followed by a phase II study. Patients receive oral capecitabine twice daily and oral sorafenib tosylate once daily on days 1-33. Patients also undergo external-beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Approximately 6 weeks after completion of neoadjuvant therapy, patients undergo surgery. After completion of study therapy, patients are followed at 8 weeks and then periodically for up to 3 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	Phase II: 2 x 825 mg/m2 per day (during 5 weeks)
DRUG	sorafenib tosylate	Phase II: 1 x 400 mg per day (during 5 weeks)
RADIATION	radiation therapy	Phase II: 1.8 Gy per day in 25 fractions (during 5 weeks)

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-05-01
• Completion: 2016-09-01
• First posted: 2009-03-26
• Last updated: 2019-05-15

Locations

18 sites across 2 countries: Hungary, Switzerland