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

NCT ID: NCT00430027

Last Updated: 2013-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-08-31

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.

Detailed 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.

Conditions

Esophageal Adenocarcinoma

Keywords

Esophageal; Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

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

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: 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

Oxaliplatin

Intervention Type: DRUG

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

Cetuximab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Cetuximab

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

Intervention Type: DRUG

Other Intervention Names

Xeloda; Eloxatin; Erbitux

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracey Schefter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado at Denver and Health Science Center

Locations

University of Colorado at Denver and Health Science Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

06-0011.cc

Identifier Type: -

Identifier Source: org_study_id