Esophageal Cancer
Conditions
Brief summary
The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.
Detailed description
Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
Interventions
DRUGErlotinib
Erlotinib
DRUGBevacizumab
Bevacizumab
DRUGPaclitaxel
Paclitaxel
DRUGCarboplatin
Carboplatin
DRUG5-FU
5-FU
PROCEDURERadiation therapy
Radiation therapy
PROCEDURESurgery
Surgery
Sponsors
Genentech, Inc.
SCRI Development Innovations, LLC
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
* Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III * No prior treatment for esophageal cancer * Must be surgical candidate based on stage and location of disease * Measurable or evaluable disease * Able to be up and perform self care * Adequate liver, renal function and bone marrow function * Patients will have to have a central venous access device placed * Able to give written informed consent. * Age 18 or older
Exclusion criteria
* Stage IV disease * Prior cancer treatment for advanced cancer in the last 5 years * Pregnant or lactating women * History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease * History of neurological disease * Recent history of blood in the sputum or vomitus * Non-healing wounds, ulcer or long bone fractures * History of bleeding problems or coagulation problems * History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months * History of uncontrolled hypertension Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | 18 months | pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 32 months | Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment. |
| Progression-Free Survival | 36 months | Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment. | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 64 years |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 62 |
| other Total, other adverse events | 59 / 62 |
| serious Total, serious adverse events | 38 / 62 |
Outcome results
Primary
Pathologic Complete Response (pCR) Rate
pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Pathologic Complete Response (pCR) Rate | 18 Participants |
Secondary
Overall Survival
Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment.
Time frame: 32 months
Population: All patients receiving a dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Overall Survival | 30.16 months |
Secondary
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment.
Time frame: 36 months
Population: All patients receiving a dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Progression-Free Survival | 28.58 months |