Esophagus Cancer
Conditions
Keywords
Esophagus Cancer
Brief summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Detailed description
Upon determination of eligibility, patients will be receive: Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
Interventions
DRUGOxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
DRUGDocetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
DRUGCapecitabine
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
RADIATIONRadiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Sponsors
Sanofi-Synthelabo
Aventis Pharmaceuticals
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction. * Must be surgical candidates * No previous treatment for esophageal cancer * Must have measurable or evaluable disease * Able to perform activities of daily living with minimal to no assistance * Adequate bone marrow, liver and kidney function * Provide written informed consent
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Tumor location in the proximal esophagus * Metastatic disease or locally advanced cancer * Moderate to severe peripheral neuropathy * Serious pre-existing medical illnesses * Significant heart disease * Treated for an invasive cancer within the previous 5 years * Women who are pregnant or breast-feeding * Age \< 18 years Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery | 18 months | The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) | 18 months | Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. |
| Overall Survival (OS) | 36 months | Length of time, in months, that patients were alive from their first date of protocol treatment until death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxaliplatin/Docetaxel/Radiation (Cohort 1) oxaliplatin, docetaxel and radiation therapy
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began. | 10 |
| Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported. | 49 |
| Total | 59 |
Baseline characteristics
| Characteristic | Oxaliplatin/Docetaxel/Radiation (Cohort 1) | Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Total |
|---|---|---|---|
| Age, Continuous | 60 years | 63 years | 61 years |
| Region of Enrollment United States | 10 participants | 49 participants | 59 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 41 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 49 / 49 |
| serious Total, serious adverse events | 2 / 10 | 33 / 49 |
Outcome results
Primary
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Time frame: 18 months
Population: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery | 24 Participants |
Secondary
Disease-Free Survival (DFS)
Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Time frame: 18 months
Population: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Disease-Free Survival (DFS) | 16.3 months |
Secondary
Overall Survival (OS)
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time frame: 36 months
Population: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | Overall Survival (OS) | 24.1 months |