Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
Stopped early · Not applicable
Conditions studied: Esophageal Adenocarcinoma
In brief
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable.
Key facts
- Study ID
- NCT00430027
- Run by
- University of Colorado, Denver
- People needed
- 8
- Starts
- 2006-11-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2013-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- signed informed consent
- patients 18 years of age or older
- biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
- clinical stage T3, N0-1 or T1-2, N1 and M0 or M1a (celiac axis lymph nodes are allowed)
- Karnofsky Performance Status of >60%
- forced expiratory volume at one second (FeV1) must be >1.0 L
- adequate bone marrow reserve equal to or absolute neutrophil count (ANC) > 1500/mcl, total white blood cell count (WBC) > 3000/mcl, platelets >100,000/mcl and hemoglobin > 10.0 g/dl (transfusion permitted)
- adequate hepatic function of direct serum bilirubin < 2 times the upper limit of normal, total bilirubin < 1.5 times the upper limit normal, alanine transaminase (ALT), aspartate transaminase (AST) < 2.5 times the upper limit normal, Alkaline phosphatase < 2.5 times the upper limit normal
- creatinine clearance > 50 ml/min
- female patients of childbearing potential must have a negative serum or urin pregnancy test within 7 days prior to starting therapy
You may not qualify if…
- no previous resection or attempted resection of an esophageal cancer
- women who are pregnant or lactating
- life expectancy < 3 months
- serious, uncontrolled concurrent infection(s)
- prior fluoropyrimidine therapy
- prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known Dihydro Pyrimidine Dehydrogenase Deficiency (DPD) deficiency
- treatment for other carcinomas within 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
- history of or evidence of uncontrolled diabetes
- surgical procedure within 6 months of study entry
- participation in any investigational drug study within 4 weeks preceding the start of study treatment
- prior therapy with andy agent that specifically targets the Epidermal Growth Factor Receptor (EGFR) pathway
- prior severe infusion reaction to a monoclonal antibody
- acute hepatitis or known HIV
- clinically significant cardia disease
- evidence of metastases
- other serious uncontrolled medical conditions that the investigator feels might compromise study participation
- major surgery within 4 weeks of the start of treatment without complete recovery
- lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- known, existing uncontrolled coagulopathy
- unwillingness to give written informed consent
- unwillingness to participate or inability to comply with the protocol for the duration of the study
- neuropathy of grade 2 or greater
Where it is running
- University of Colorado at Denver and Health Science Center — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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