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A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
Not Recruiting
Trial ID: NCT00226941
Purpose
The objectives of this study are to:
1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
2. To determine the maximum-tolerated dose (MTD) when capecitabine
* oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)
Official Title
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Andrew A. Shelton, MD, FACS, FACRS
Clinical Professor, Surgery - General Surgery
Eligibility
INCLUSION CRITERIA
* Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge.
* Age ≥ 18
* Karnofsky performance status (KPS) ≥ 70
* Leukocyte count \> 3,500 x 10e6/µL
* Platelet count \> 100,000/µL
* Serum glutamic-oxaloacetic transaminase (SGOT) \< 2.5 x institutional upper limits of normal (ULN)
* Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x ULN
* Alkaline phosphatase \< 2.5 x ULN
* Total bilirubin \< 1.5x ULN
* Creatinine:
* Within normal institutional limits
* OR
* Creatinine clearance \> 60 mL/min/1.73 m2 (if serum creatinine levels above institutional normal)
* Ability to swallow pills without difficulty
* Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication
* Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment
EXCLUSION CRITERIA
* Metastatic (M1) or stage IV disease
* Prior history of treatment with cetuximab or other therapy targeting EGFR
* Prior history of anti-cancer murine monoclonal antibody therapy
* Prior pelvic or whole abdominal radiotherapy
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness / social situations that would limit compliance with study requirements
* Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion)
* Inability to sign written consent
* Pregnant or breastfeeding
* Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study
Intervention(s):
drug: Capecitabine
drug: Cetuximab
drug: Oxaliplatin
drug: Diphenhydramine hydrochloride (HCl)
radiation: Radiotherapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Heidi Kaiser
6507240079