Trial Outcomes & Findings for Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer (NCT NCT00702884)

NCT ID: NCT00702884

Last Updated: 2017-03-21

Results Overview

Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: up to 24 weeks
• Results posted on: 2017-03-21

Participant Flow

Participant milestones

Measure	Sunitinib Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle
Age, Customized	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race/Ethnicity, Customized White	23 patients n=5 Participants
Race/Ethnicity, Customized Black	2 patients n=5 Participants
Region of Enrollment United States	25 patients n=5 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks

Outcome measures

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle	Grade 3 Adverse Events Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated	Grade 4 Adverse Events Grade 4=Life-threatening consequences; urgent intervention indicated
Progression-free Survival Rate	7 weeks Interval 5.6 to 11.4	—	—

SECONDARY outcome

Timeframe: up to 4 years

Population: Durable Complete Response= PR + SD \> 10 weeks

The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Outcome measures

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle	Grade 3 Adverse Events Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated	Grade 4 Adverse Events Grade 4=Life-threatening consequences; urgent intervention indicated
Overall Response Rate	10 patients	—	—

SECONDARY outcome

Timeframe: up to 4 years

The median overall survival time will be reported using the 95% confidence intervals for the parameters.

Outcome measures

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle	Grade 3 Adverse Events Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated	Grade 4 Adverse Events Grade 4=Life-threatening consequences; urgent intervention indicated
Median Overall Survival Time	16.6 weeks Interval 8.9 to 25.3	—	—

SECONDARY outcome

Timeframe: up to 4 years

Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.

Outcome measures

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle	Grade 3 Adverse Events Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated	Grade 4 Adverse Events Grade 4=Life-threatening consequences; urgent intervention indicated
Median Progression-free Survival Time	6.9 weeks Interval 5.6 to 11.4	—	—

SECONDARY outcome

Timeframe: up to 4 years

The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.

Outcome measures

Measure	Sunitinib n=25 Participants Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle	Grade 3 Adverse Events n=25 Participants Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated	Grade 4 Adverse Events n=25 Participants Grade 4=Life-threatening consequences; urgent intervention indicated
Frequency and Severity of Adverse Events Fatigue	52 percentage of patients	24 percentage of patients	0 percentage of patients
Frequency and Severity of Adverse Events Anemia	48 percentage of patients	12 percentage of patients	8 percentage of patients
Frequency and Severity of Adverse Events Thrombocytopenia	12 percentage of patients	12 percentage of patients	4 percentage of patients
Frequency and Severity of Adverse Events Leukopenia	32 percentage of patients	12 percentage of patients	4 percentage of patients

SECONDARY outcome

Timeframe: up to 4 years

Population: Insufficient tissue was available and the analysis for mean vessel density not performed

Quantitative assessment of proliferating tumor cells, and apoptosis, of the laboratory and radiographic correlates, the analyses will be purely explorative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 years

Population: Analysis for tumor cells not performed due to insufficient samples available

Biopsy sample taken from patients before and after treatment Apoptosis measures using the terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay, which measures 3' nicked DNA. DNA is degraded in the early steps of apoptosis into low molecular weight (LMW) fragments and the production of single strand breaks in the high molecular weight DNA.Both of these features of apoptosis can be detected by labeling free 3'-OH termini with modified nucleotides, in our case this will be biotin-labeled dUTP. Terminal deoxynucleotidyl transferase (TdT) is an enzyme that labels blunt-ends of DNA breaks and can catalyze polymerization of nucleotides to free 3'-OH DNA ends in a template-independent manner. The newly incorporated nucleotides are detected by a secondary antibody, avidin-peroxidase. After substrate reaction, the stained cells can be detected and counted under a light microscope. Apoptotic cells will be fixed with formaldehyde which links LMW DNA

Outcome measures

Outcome data not reported

Adverse Events

Sunitinib

Serious events: 25 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sunitinib n=25 participants at risk Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle
General disorders Fatigue	16.0% 4/25 • Number of events 4 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Abdominal Pain	8.0% 2/25 • Number of events 2 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Blood and lymphatic system disorders Leukopenia	8.0% 2/25 • Number of events 2 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Blood and lymphatic system disorders Thrombocytopenia	4.0% 1/25 • Number of events 1 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders GI Hemorrhage	8.0% 2/25 • Number of events 2 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Blood and lymphatic system disorders Anemia	20.0% 5/25 • Number of events 5 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Vascular disorders Hypertension	4.0% 1/25 • Number of events 1 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Blood and lymphatic system disorders Neutropenia	32.0% 8/25 • Number of events 8 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0

Other adverse events

Measure	Sunitinib n=25 participants at risk Sunitinib 37.5 mg daily for a 4 week cycle sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle
Investigations Leukopenia	40.0% 10/25 • Number of events 10 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Investigations Lymphopenia	28.0% 7/25 • Number of events 7 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Investigations Neutropenia	32.0% 8/25 • Number of events 8 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Blood and lymphatic system disorders Anemia	48.0% 12/25 • Number of events 12 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Injury, poisoning and procedural complications Thrombocytopenia	24.0% 6/25 • Number of events 6 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Metabolism and nutrition disorders Anorexia	48.0% 12/25 • Number of events 12 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Diarrhoea	44.0% 11/25 • Number of events 11 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
General disorders Fatigue	60.0% 15/25 • Number of events 15 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Mucositis	28.0% 7/25 • Number of events 7 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Vascular disorders Hypertension	8.0% 2/25 • Number of events 2 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders GI Hemorrhage	20.0% 5/25 • Number of events 5 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Metabolism and nutrition disorders Hyperglycaemia	32.0% 8/25 • Number of events 8 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Abdominal pain	40.0% 10/25 • Number of events 10 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Nausea	52.0% 13/25 • Number of events 13 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0
Gastrointestinal disorders Vomiting	36.0% 9/25 • Number of events 9 Toxicities were graded according to NCI Common Toxicity Criteria version 3.0

Additional Information

Tanios Bekaii-Saab

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-6529

Email: Tanios.Bekaii-Saab@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60