NCT00439608

Brief Summary

Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 1, 2013

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

5.5 years

First QC Date

February 22, 2007

Results QC Date

May 9, 2013

Last Update Submit

February 13, 2020

Conditions

Esophageal CancerGastric Cancer

Keywords

esophageal cancergastroesophageal cancergastric cancer

Outcome Measures

Primary Outcomes (1)

  • Reponse Rate at Time of Surgery by Tissue

    pathologic complete response rate at surgery

    within 30 days of last treatment

Secondary Outcomes (1)

  • Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.

    baseline, then during treatment, about 5 weeks through 30 days post treatment.

Study Arms (1)

Treatment

EXPERIMENTAL

Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.

Drug: Cetuximab,Paclitaxel, Carboplatin

Interventions

Cetuximab,Paclitaxel, CarboplatinDRUG

IV treatment for 6 weeks

Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
  • Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy.
  • There must be no evidence of distant organ metastases.
  • No prior radiation for gastric or esophageal cancer.
  • Patients must be \> 18 years of age, and nonpregnant
  • Patients must have an ANC \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2 x upper limit normal (ULN) and bilirubin \< 1.5 x ULN, and AST \< 3 x ULN.
  • ECOG performance status 0-2.
  • Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy.
  • Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible.
  • All patients must sign informed consent

You may not qualify if:

  • Any of the following criteria will make the patient ineligible to participate in this study:
  • Acute hepatitis or AIDS.
  • Active or uncontrolled infection.
  • Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • Prior therapy which specifically and directly targets the EGFR pathway.
  • Prior severe infusion reaction to a monoclonal antibody.
  • Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University Oncology Group

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

CetuximabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Howard Safran, MD
Organization
BrUOG
Hsafran@lifespan.org
401-863-3000

Study Officials

  • Howard Safran, MD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Principal Investigator

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 23, 2007

Study Start

October 1, 2004

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 17, 2020

Results First Posted

July 1, 2013

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)