Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With selenomethionine and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well selenomethionine works when given together with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery for newly diagnosed stage II or stage III rectal cancer.
|Colorectal Cancer||Dietary Supplement: selenomethionine Drug: capecitabine Drug: oxaliplatin Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma|
- Complete Pathological Response Rate [ Time Frame: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. ]
- Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy [ Time Frame: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. ]
- Safety and Tolerability as Assessed by NCI CTCAE Version 3.0 [ Time Frame: Adverse events were queried for and collected every cycle for the duration of treatment. ]
- Dose Intensity [ Time Frame: During treatment with capecitabine, oxaliplatin, selenomethionine. ]
- Local Relapse Rate [ Time Frame: For up to 5 years following surgery. ]
- Distant Relapse Rate [ Time Frame: For up to 5 years following surgery. ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- To determine the complete pathological response rate of the combination of capecitabine, oxaliplatin, selenomethionine, and radiotherapy in patients with stage II or III rectal adenocarcinoma.
- To determine the T-downstaging rate with this regimen in patients with stage II or III rectal adenocarcinoma.
- To determine the safety of this regimen by assessing toxicity and dose intensity of the various components of this regimen.
- To determine the rate of local relapse.
- To determine the rate of distant relapse.
OUTLINE: Patients receive neoadjuvant therapy comprising oral selenomethionine twice daily for 1 week prior to radiotherapy and then once daily for 6 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1-7 and oral capecitabine twice daily on days 1-5 for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after completion of neoadjuvant therapy, patients undergo curative-intent surgery. Beginning 4-8 weeks after surgery, patients may receive up to 9 courses of standard adjuvant combination chemotherapy (FOLFOX).
Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration. Pharmacokinetic studies are also performed.
After completion of study treatment, patients are followed for up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625183
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Marwan Fakih, MD||Roswell Park Cancer Institute|