A Phase 2 interventional study of Erlotinib and Bevacizumab in Esophageal Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
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.
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 62 is close to the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
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.
Drug: Erlotinib · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin · Drug: 5-FU · Procedure: Radiation therapy · Procedure: Surgery
Erlotinib
Also known as: Tarceva
Bevacizumab
Also known as: Avastin
Paclitaxel
Also known as: Taxol
Carboplatin
Also known as: Paraplatin
5-FU
Also known as: Fluorouracil
Radiation therapy
Surgery
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
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
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
| Milestone | Treatment |
|---|---|
| Started | 62 |
| Completed | 44 |
| Not completed | 18 |
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.
| Participants | Treatment |
|---|---|
| Pathologic Complete Response (pCR) Rate | 18 |
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.
| months | Treatment |
|---|---|
| Overall Survival | 30.16 (19.35 to NA) |
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.
| months | Treatment |
|---|---|
| Progression-Free Survival | 28.58 (14.39 to NA) |
Collected over 32 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 29/62 (46.8%) | 38/62 (61.3%) | 59/62 (95.2%) |
| Event | Treatment |
|---|---|
| DehydrationGastrointestinal disorders | 10/62 |
| Febrile NeutropeniaInfections and infestations | 6/62 |
| EsophagitisGastrointestinal disorders | 5/62 |
| DeathGeneral disorders | 3/62 |
| DiarrheaGastrointestinal disorders | 3/62 |
| LeukocytesBlood and lymphatic system disorders | 2/62 |
| Supraventricular arrhythmia - atrial fibrillationCardiac disorders | 2/62 |
| Intraop Injury - AbdominalSurgical and medical procedures | 2/62 |
| TachycardiaCardiac disorders | 1/62 |
| Peripheral Arterial IschemiaVascular disorders | 1/62 |
| Event | Treatment |
|---|---|
| LeukocytesBlood and lymphatic system disorders | 40/62 |
| NeutrophilsBlood and lymphatic system disorders | 27/62 |
| Mucositis - Oral CavityGastrointestinal disorders | 26/62 |
| DehydrationGastrointestinal disorders | 19/62 |
| DiarrheaGastrointestinal disorders | 17/62 |
| EsophagitisGastrointestinal disorders | 17/62 |
| AnorexiaGastrointestinal disorders | 10/62 |
| FatigueGeneral disorders | 9/62 |
| RashSkin and subcutaneous tissue disorders | 9/62 |
| PlateletsBlood and lymphatic system disorders | 5/62 |
| Age, Continuous(years) | Treatment |
|---|---|
| Median | 64 (43 to 76) |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 5 |
| Male | 57 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 62 |
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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SCRI Development Innovations, LLC