A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Rectal Cancer, Colo-rectal Cancer
In brief
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)
Key facts
- Study ID
- NCT00226941
- Run by
- George Albert Fisher
- People needed
- 23
- Starts
- 2004-06-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2017-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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