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

Gastric Cancer Clinical Trial

Official title:

Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439608
• Other study ID #: BrUOG-EG-203
• Secondary ID: BMS#CA225091
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: April 2010

Study information

• Verified date: February 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT01904435

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Cetuximab,Paclitaxel, Carboplatin
IV treatment for 6 weeks

Locations

Country	Name	City	State
United States	Brown University Oncology Group	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reponse Rate at Time of Surgery by Tissue	pathologic complete response rate at surgery	within 30 days of last treatment
Secondary	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.	CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.	baseline, then during treatment, about 5 weeks through 30 days post treatment.