Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
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.
Radiation: Radiation Therapy (XRT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal|
- 2 Year Failure Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
- Number of Participants With Complete Response at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Number of Participants With 2-year Colostomy-Free Survival [ Time Frame: 2 Years with median study follow up of 19 months ] [ Designated as safety issue: No ]Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.
- 2-year Local Regional Control [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- 2-Year Median Overall Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Number of Participants With Progression-Free Survival at 2-Year [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine + Oxaliplatin + XRT
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.
825 mg/m^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
Other Name: XelodaDrug: Oxaliplatin
50 mg/m^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
Other Name: EloxatinRadiation: 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093379
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Cathy Eng, MD||M.D. Anderson Cancer Center|
|Study Chair:||Christopher H. Crane, MD||M.D. Anderson Cancer Center|