Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Launched by UNIVERSITY COLLEGE, LONDON · Sep 5, 2009

Keywords

ClinConnect Summary

OBJECTIVES:

* To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.

Patients undergo surgery 8 weeks after completion of chemoradi...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed adenocarcinoma of the rectum
• * MRI-defined locally advanced disease, as defined by 1 of the following:
• • Mesorectal fascia involvement
• • Mesorectal fascia threatened (tumor ≤ 1 mm from mesorectal fascia)
• • Any T3 tumor \< 5 cm from anal verge
• • No evidence of metastatic disease
• PATIENT CHARACTERISTICS:
• • ECOG or WHO performance status 0-1
• • ANC ≥ 1.5 x 10\^9/L
• • Platelet count ≥ 100 x 10\^9/L
• • Serum bilirubin \< 1.25 times upper limit of normal (ULN)
• • Serum transaminase(s) \< 3 times ULN
• • Serum alkaline phosphatase \< 5 times ULN
• • Estimated glomerular filtration rate \> 50 mL/min
• • Not pregnant or nursing
• • Fertile patients must use effective contraception
• • Fit to receive all study treatments
• • Able to comply with oral medication
• • No comorbidity or coagulation problem that would deem the patient unsuitable for surgery
• • No pre-existing condition that would preclude radiotherapy (e.g., fistulas, severe ulcerative colitis \[particularly patients currently taking sulfasalazine\], Crohn's disease, prior adhesions)
• • No current or impending rectal obstruction (unless a defunctioning stoma is present) or metallic colonic rectal stent in situ
• • No significant small bowel delineated within the radiotherapy fields
• • No pelvic sepsis
• • No gastrointestinal disorder that would interfere with oral therapy or oral bioavailability
• • No uncontrolled cardiac, respiratory, or other disease that would preclude study therapy or informed consent
• • No serious medical or psychiatric disorder that would preclude study therapy or informed consent
• • No known dihydropyrimidine dehydrogenase deficiency
• PRIOR CONCURRENT THERAPY:
• • No prior chemotherapy
• • No prior radiotherapy to the pelvis
• • No concurrent participation in other studies, except genetic studies (e.g., NSCCG-National Study of Colorectal Cancer Genetics)
• • No concurrent St. John wort
• • No other concurrent cytotoxic treatment or radiotherapy