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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