Clinical trial NCT00439608: Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Official title: Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: esophageal cancer
gastroesophageal cancer
gastric cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Reponse Rate at Time of Surgery by Tissue
timeFrame: within 30 days of last treatment
Secondary outcomes:
measure: 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.
timeFrame: baseline, then during treatment, about 5 weeks through 30 days post treatment.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University Oncology Group
state: Rhode Island
Study officials:
affiliation: Brown University
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
References: