NCT00093379

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.

Detailed description

OBJECTIVES: Primary * Determine time to treatment failure in patients with stage II-IIIB squamous cell carcinoma of the anal canal treated with capecitabine, oxaliplatin, and radiotherapy (i.e. Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT) shortened to XELOX/XRT). * Determine the toxic effects of this regimen in these patients. Secondary * Determine the complete response rate in patients treated with this regimen. * Determine 2-year local regional control in patients treated with this regimen. * Determine 2-year colostomy-free survival in patients treated with this regimen. * Determine 2-year median overall survival in patients treated with this regimen. * Determine 2-year progression-free survival in patients treated with this regimen. OUTLINE: Patients receive oral capecitabine\* twice daily on days 1-2, 6-10, 20-24, 27-31, and 41-42, and undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Patients also receive oxaliplatin intravenous (IV) over 2 hours on days 1, 8, 22, and 29. Treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo radiotherapy once daily on days 43 and 44. Patients are followed at 4-6 and 12 weeks and then periodically thereafter. PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
DRUG	Oxaliplatin	50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
RADIATION	Radiation Therapy (XRT)	Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.

Timeline

• Start date: 2004-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2004-10-08
• Last updated: 2023-04-18
• Results posted: 2014-04-17

Locations

1 site across 1 country: United States