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

NCT00430027 | Terminated Results DMC

• 1 other identifier: 06-0011.cc
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Adenocarcinoma

Keywords

Esophageal; Esophagus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

EXPERIMENTAL

Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cetuximab

Interventions

Capecitabine DRUG

Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4

Also known as: Xeloda

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

Oxaliplatin DRUG

Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4

Also known as: Eloxatin

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

Cetuximab DRUG

Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

Also known as: Erbitux

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Bristol-Myers Squibb: collaborator
• Sanofi: collaborator

Study Sites (1)

University of Colorado at Denver and Health Science Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Capecitabine; Oxaliplatin; Cetuximab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was terminated due slow accrual.

Results Point of Contact

• Title: Dr. Tracey Schefter
• Organization: University of Colorado, Denver

Tracey.Schefter@ucdenver.edu

720-848-0100

Study Officials

• Tracey Schefter, MD

  University of Colorado at Denver and Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 12, 2013
• Results First Posted: December 12, 2013

Record last verified: 2013-10

Locations

US (1)