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

Primary Purpose

Esophageal Adenocarcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Capecitabine

Oxaliplatin

Cetuximab

About this trial

This is an interventional treatment trial for Esophageal Adenocarcinoma focused on measuring Esophageal, Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado at Denver and Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00430027

First Posted

January 30, 2007

Last Updated

October 22, 2013

Sponsor

University of Colorado, Denver

Collaborators

Bristol-Myers Squibb, Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00430027

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated due slow accrual.

Study Start Date

November 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

Bristol-Myers Squibb, Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Adenocarcinoma

Keywords

Esophageal, Esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine, oxaliplatin, cetuximab, and radiation therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Toxicity

Description

Time Frame

Up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tracey Schefter, MD

Organizational Affiliation

University of Colorado at Denver and Health Science Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado at Denver and Health Science Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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