Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer

NCT ID: NCT00439608

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2010-04-30

Brief Summary

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

Detailed Description

The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

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

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Cetuximab,Paclitaxel, Carboplatin

Intervention Type: DRUG

IV treatment for 6 weeks

Interventions

Cetuximab,Paclitaxel, Carboplatin

IV treatment for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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).

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

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

howard safran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard Safran, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University Oncology Group

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

BMS#CA225091

Identifier Type: OTHER

Identifier Source: secondary_id

BrUOG-EG-203

Identifier Type: -

Identifier Source: org_study_id

NCT01904435

Identifier Type: -

Identifier Source: nct_alias