A Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Radiation in Combination With Capecitabine & Paniumumab With and Without Irinotecan in Patients With Localized Rectal Cancer
- To assess the pathological tumor response rate in patients with localized rectal cancer
treated with neoadjuvant chemoradiotherapy comprising capecitabine, panitumumab, and
radiotherapy with or without irinotecan hydrochloride.
- To assess the incidence of grade 3/4 toxicity during neoadjuvant chemoradiotherapy.
- To assess the disease-free survival.
- To assess the time to treatment failure.
- To assess the1-year and 2-year survival rates.
- To assess local recurrence, defined as recurrence in pelvis at the site of previous
- To assess the safety and toxicity grade using NCI CTCAE v3.0 criteria.
- To assess the number and percentage of patients who undergo down staging of their
disease as determined before initiating neoadjuvant therapy and at the time of surgery.
- To assess the number and percentage of patients where permanent colostomy can be
avoided as determined by the surgeon before initiating neoadjuvant therapy and at the
time actual surgery is performed.
OUTLINE: This is a multicenter study.
- Phase A: Patients undergo radiotherapy once daily 5 days a week and receive oral
capecitabine twice daily 5 days a week for 5½ weeks. Patients also receive panitumumab
IV over 1 hour on days 1, 15, and 29 during radiotherapy in the absence of disease
progression or unacceptable toxicity.
- Phase B: Patients undergo radiotherapy and receive capecitabine and panitumumab as in
Phase A. Patients also receive irinotecan hydrochloride IV on days 1, 8, 22, and 29 in
the absence of disease progression or unacceptable toxicity.
Patients undergo surgery 6-8 weeks after completion of chemoradiotherapy,
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months thereafter.
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate
Imtiaz A. Malik, MD
Loma Linda Oncology Medical Group, Incorporated
|New Hope Cancer and Research Institute - Pomona||Pomona, California 91767|
|Davood Vafai, MD, Medical Offices, Incorporated||Redlands, California 92374|
|Loma Linda Oncology Medical Group, Incorporated||Redlands, California 92374|
|New Hope Cancer and Research Institute - Glendora||Redlands, California 92374|