Esophageal Cancer, Gastric Cancer
Conditions
Keywords
esophageal cancer, gastroesophageal cancer, gastric cancer
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.
Interventions
DRUGCetuximab,Paclitaxel, Carboplatin
IV treatment for 6 weeks
Sponsors
Bristol-Myers Squibb
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reponse Rate at Time of Surgery by Tissue | within 30 days of last treatment | pathologic complete response rate at surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity. |
Countries
United States
Participant flow
Recruitment details
60 patients were enrolled at multiple hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| Treatment Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 60 |
| other Total, other adverse events | 60 / 60 |
| serious Total, serious adverse events | 7 / 60 |
Outcome results
Primary
Reponse Rate at Time of Surgery by Tissue
pathologic complete response rate at surgery
Time frame: within 30 days of last treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Reponse Rate at Time of Surgery by Tissue | 40 participants |
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.
Time frame: baseline, then during treatment, about 5 weeks through 30 days post treatment.
Population: 60 patients were analyzed for toxicity but 57 for overall response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | 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. | 37 participants |