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

Esophageal Adenocarcinoma Clinical Trial

Official title:

Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00430027
• Other study ID #: 06-0011.cc
• Status: Terminated
• Phase: N/A
• First received: January 30, 2007
• Last updated: October 22, 2013
• Start date: November 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Capecitabine
Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
• Oxaliplatin
Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
• Cetuximab
Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

Locations

Country	Name	City	State
United States	University of Colorado at Denver and Health Science Center	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Bristol-Myers Squibb, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Toxicity	The primary objective of this pilot study was 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 with acceptable toxicity profile.	Up to 4 weeks	Yes