Status:
COMPLETED
Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
Lead Sponsor:
University College, London
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: * To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00972881
Start Date
April 1 2009
End Date
December 31 2016
Last Update
October 25 2017
Active Locations (5)
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1
Yorkshire Regional Clinical Trials & Research Unit
Leeds, England, United Kingdom, LS16 6QB
2
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
3
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
4
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT