Clinical trial NCT00093379
Conditions: Anal Cancer
Keywords: stage II anal cancer stage IIIA anal cancer stage IIIB anal cancer squamous cell carcinoma of the anus Capecitabine Xeloda Oxaliplatin Eloxatin Radiotherapy XRT
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-04-01; Completion date: 2012-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Radiation Therapy (XRT)
Intervention descriptions: intervention 1: 825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5. intervention 2: 50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29. intervention 3: 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.

Protocol documents: