Back to resultsCetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Primary Purpose
Esophageal Cancer, Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab,Paclitaxel, Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, gastroesophageal cancer, gastric cancer
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).
Sites / Locations
- Brown University Oncology Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
Outcomes
Primary Outcome Measures
Reponse Rate at Time of Surgery by Tissue
pathologic complete response rate at surgery
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00439608
First Posted
February 22, 2007
Last Updated
February 13, 2020
Sponsor
Brown University
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00439608
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
esophageal cancer, gastroesophageal cancer, gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
Intervention Type
Drug
Intervention Name(s)
Cetuximab,Paclitaxel, Carboplatin
Intervention Description
IV treatment for 6 weeks
Primary Outcome Measure Information:
Title
Reponse Rate at Time of Surgery by Tissue
Description
pathologic complete response rate at surgery
Time Frame
within 30 days of last treatment
Secondary Outcome Measure Information:
Title
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.
Description
CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.
Time Frame
baseline, then during treatment, about 5 weeks through 30 days post treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University Oncology Group
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
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