Trial Outcomes & Findings for Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer (NCT NCT00393068)

NCT ID: NCT00393068

Last Updated: 2022-03-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2022-03-02

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	62
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

Baseline characteristics by cohort

Measure	Treatment n=62 Participants 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.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Treatment n=62 Participants 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.

Pathologic Complete Response (pCR) Rate

18 Participants

SECONDARY outcome

Timeframe: 32 months

Population: All patients receiving a dose of study drug.

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.

Outcome measures

Measure

Treatment n=62 Participants 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.

Overall Survival

30.16 months Interval 19.35 to Upper confidence limit is not estimable by Kaplan-Meier method due to insufficient observed events.

SECONDARY outcome

Timeframe: 36 months

Population: All patients receiving a dose of study drug.

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.

Outcome measures

Measure

Treatment n=62 Participants 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.

Progression-Free Survival

28.58 months Interval 14.39 to Upper confidence limit is not estimable by Kaplan Meier method due to insufficient observed events.

Adverse Events

Treatment

Serious events: 38 serious events

Other events: 59 other events

Deaths: 29 deaths

Serious adverse events

Measure	Treatment n=62 participants at risk 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.
Blood and lymphatic system disorders Leukocytes	3.2% 2/62 • Number of events 2 • 32 months
Infections and infestations Febrile Neutropenia	9.7% 6/62 • Number of events 6 • 32 months
Cardiac disorders Supraventricular arrhythmia - atrial fibrillation	3.2% 2/62 • Number of events 2 • 32 months
Cardiac disorders Tachycardia	1.6% 1/62 • Number of events 1 • 32 months
Vascular disorders Peripheral Arterial Ischemia	1.6% 1/62 • Number of events 1 • 32 months
General disorders Fever	1.6% 1/62 • Number of events 1 • 32 months
General disorders Fatigue	1.6% 1/62 • Number of events 1 • 32 months
General disorders Death	4.8% 3/62 • Number of events 3 • 32 months
Gastrointestinal disorders Colitis	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders Dehydration	16.1% 10/62 • Number of events 10 • 32 months
Gastrointestinal disorders Diarrhea	4.8% 3/62 • Number of events 3 • 32 months
Gastrointestinal disorders Esophagitis	8.1% 5/62 • Number of events 6 • 32 months
Gastrointestinal disorders Ileus	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders Mucositis	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders Nausea	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders GI - Other	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders Malnutrition	1.6% 1/62 • Number of events 1 • 32 months
Gastrointestinal disorders Hemorrhage - GI	1.6% 1/62 • Number of events 1 • 32 months
Infections and infestations Sepsis	1.6% 1/62 • Number of events 1 • 32 months
Infections and infestations Infection	1.6% 1/62 • Number of events 2 • 32 months
Nervous system disorders Syncope	1.6% 1/62 • Number of events 1 • 32 months
Nervous system disorders Confusion	1.6% 1/62 • Number of events 1 • 32 months
Respiratory, thoracic and mediastinal disorders Dyspnea	1.6% 1/62 • Number of events 1 • 32 months
Respiratory, thoracic and mediastinal disorders ARDS	1.6% 1/62 • Number of events 1 • 32 months
Surgical and medical procedures Intraop Injury - Abdominal	3.2% 2/62 • Number of events 2 • 32 months
Surgical and medical procedures Intraop Injury - Esophagus	1.6% 1/62 • Number of events 1 • 32 months
Vascular disorders Thrombosis/Thrombus/Embolism	1.6% 1/62 • Number of events 1 • 32 months

Other adverse events

Measure	Treatment n=62 participants at risk 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.
Blood and lymphatic system disorders Leukocytes	64.5% 40/62 • Number of events 40 • 32 months
Blood and lymphatic system disorders Neutrophils	43.5% 27/62 • Number of events 27 • 32 months
Blood and lymphatic system disorders Platelets	8.1% 5/62 • Number of events 5 • 32 months
Blood and lymphatic system disorders Anemia	6.5% 4/62 • Number of events 4 • 32 months
Gastrointestinal disorders Mucositis - Oral Cavity	41.9% 26/62 • Number of events 26 • 32 months
Gastrointestinal disorders Dehydration	30.6% 19/62 • Number of events 19 • 32 months
Gastrointestinal disorders Diarrhea	27.4% 17/62 • Number of events 17 • 32 months
Gastrointestinal disorders Esophagitis	27.4% 17/62 • Number of events 17 • 32 months
Gastrointestinal disorders Anorexia	16.1% 10/62 • Number of events 10 • 32 months
General disorders Fatigue	14.5% 9/62 • Number of events 9 • 32 months
Skin and subcutaneous tissue disorders Rash	14.5% 9/62 • Number of events 9 • 32 months
Gastrointestinal disorders Nausea	6.5% 4/62 • Number of events 4 • 32 months
Gastrointestinal disorders Hemorrhage - GI	4.8% 3/62 • Number of events 3 • 32 months
Vascular disorders Thrombosis/Thrombus/Embolism	6.5% 4/62 • Number of events 4 • 32 months

Additional Information

Johanna C. Bendell, MD

Sarah Cannon Research Institute

Phone: 615-329-7274

Email: jbendell@tnonc.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
• Publication restrictions are in place

Restriction type: OTHER