Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Bristol-Myers Squibb; Sanofi
• Treatments: Capecitabine; Cetuximab; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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