NCT00165490

Brief Summary

The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

3.3 years

First QC Date

September 9, 2005

Last Update Submit

November 7, 2014

Conditions

Adenocarcinoma of EsophagusSquamous Cell Carcinoma of Esophagus

Keywords

adenocarcinoma of esophagussquamous cell carcinoma of esophaguscombination chemotherapycisplatinirinotecanradiation therapyresectable esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.

    3 years

Secondary Outcomes (2)

  • To determine the safety of the drug combination and radiation therapy

    3 years

  • To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.

Interventions

CetuximabDRUG

Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.

CisplatinDRUG

Given once per week on weeks 1, 2, 4,and 5.

IrinotecanDRUG

Given once per week on weeks 1, 2, 4,and 5.

Radiation therapyDEVICE

Once daily for 28 treatments (5 1/2 weeks)

SurgeryPROCEDURE

Surgery performed 4-8 weeks after chemoradiation therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Negative pregnancy test
  • Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
  • ECOG performance status of 0 or 1.
  • Neutrophils greater or equal to 1,500/ul
  • Platelets greater or equal to 100,000/ul
  • Serum bilirubin less or equal to 1.5mg/ul
  • Serum creatinine less or equal to 1.5mg/ul
  • AST or SGOT less or equal to 2.5x upper normal limit
  • Alkaline phosphatase less or equal to 5x upper normal limit

You may not qualify if:

  • Prior surgery for esophageal or gastro-esophageal junction cancer.
  • Prior chemotherapy or radiation therapy
  • Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
  • Metastatic disease to distant organs or non-regional lymph nodes.
  • Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
  • Pregnant or lactating women
  • Other active malignancy
  • Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
  • History of seizure disorder
  • Uncontrolled diarrhea
  • Peripheral neuropathy (Grade 2)
  • Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusEsophageal Squamous Cell Carcinoma

Interventions

CetuximabCisplatinIrinotecanRadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • Peter Enzinger, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Overall PI

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(2)