A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
- 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
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete pathological response rate
Marwan Fakih, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|