Trial Outcomes & Findings for Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer (NCT NCT00917462)
NCT ID: NCT00917462
Last Updated: 2019-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
2 months
Results posted on
2019-03-27
Participant Flow
Participant milestones
| Measure |
Sorafenib
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Sorafenib
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Overall Study
Clinical Deterioration
|
1
|
Baseline Characteristics
Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib
n=35 Participants
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsOutcome measures
| Measure |
Sorafenib
n=35 Participants
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
2-month Progression-free Survival (PFS) of Sorafenib in Patients With Metastatic or Recurrent Esophageal and Gastroesophageal (GE) Junction Cancer.
Progression Free
|
20 Participants
|
|
2-month Progression-free Survival (PFS) of Sorafenib in Patients With Metastatic or Recurrent Esophageal and Gastroesophageal (GE) Junction Cancer.
Progressed
|
14 Participants
|
|
2-month Progression-free Survival (PFS) of Sorafenib in Patients With Metastatic or Recurrent Esophageal and Gastroesophageal (GE) Junction Cancer.
Not evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: after the first four weeks of therapy, at eight weeks, and every eight weeks thereafter, an average of 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Sorafenib
n=35 Participants
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Overall Response Rate (Partial Response and Complete Response) of Sorafenib.
Disease Progression
|
14 Participants
|
|
Overall Response Rate (Partial Response and Complete Response) of Sorafenib.
Stable Disease
|
19 Participants
|
|
Overall Response Rate (Partial Response and Complete Response) of Sorafenib.
Complete Response
|
1 Participants
|
|
Overall Response Rate (Partial Response and Complete Response) of Sorafenib.
Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: every week while on studyOutcome measures
| Measure |
Sorafenib
n=35 Participants
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Number of Participants With Adverse Events
|
35 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: anytime prior to enrollment or during protocol therapyOutcome measures
| Measure |
Sorafenib
n=35 Participants
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Percentage of Tumors With High Phosphorylated Extracellular Signal-regulated Kinase Expression
|
65 % of tumors with high pERK expression
|
Adverse Events
Sorafenib
Serious events: 15 serious events
Other events: 34 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Sorafenib
n=35 participants at risk
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
Investigations
Hyperbilirubinemia
|
2.9%
1/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/35 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
5.7%
2/35 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Up to 2 years
|
|
General disorders
Constitutional Symptoms, Other
|
2.9%
1/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.4%
4/35 • Up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
2.9%
1/35 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Up to 2 years
|
|
General disorders
Edema: viscera
|
2.9%
1/35 • Up to 2 years
|
|
General disorders
Fatigue
|
5.7%
2/35 • Up to 2 years
|
|
General disorders
Fever
|
2.9%
1/35 • Up to 2 years
|
|
Gastrointestinal disorders
Fistula - GI, Esophagus
|
5.7%
2/35 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Up to 2 years
|
|
Infections and infestations
Pleural Infection
|
2.9%
1/35 • Up to 2 years
|
|
Nervous system disorders
Motor neuropathy
|
5.7%
2/35 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest Wall
|
2.9%
1/35 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Up to 2 years
|
|
General disorders
Pain - Other
|
2.9%
1/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Up to 2 years
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.9%
1/35 • Up to 2 years
|
|
General disorders
Rigors/Chills
|
2.9%
1/35 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
2.9%
1/35 • Up to 2 years
|
|
Cardiac disorders
Sinus Tachycardia
|
2.9%
1/35 • Up to 2 years
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.9%
1/35 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Up to 2 years
|
Other adverse events
| Measure |
Sorafenib
n=35 participants at risk
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Sorafenib, administered orally: Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
|
|---|---|
|
General disorders
Fatigue
|
85.7%
30/35 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
51.4%
18/35 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
34.3%
12/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - other
|
28.6%
10/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Albumin, low
|
25.7%
9/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.7%
9/35 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin/Anemia
|
25.7%
9/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
22.9%
8/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
22.9%
8/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
7/35 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
5/35 • Up to 2 years
|
|
Investigations
Weight Loss
|
14.3%
5/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
4/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.4%
4/35 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis
|
11.4%
4/35 • Up to 2 years
|
|
Nervous system disorders
Sensory Neuropathy
|
11.4%
4/35 • Up to 2 years
|
|
Investigations
Platelets
|
11.4%
4/35 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Rash/desquamation
|
11.4%
4/35 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.4%
4/35 • Up to 2 years
|
|
Investigations
ALT/Alkaline phosphatase increased
|
8.6%
3/35 • Up to 2 years
|
|
Investigations
AST/Aspartate aminotransferase increased
|
8.6%
3/35 • Up to 2 years
|
|
Investigations
Alkaline Phosphatase
|
8.6%
3/35 • Up to 2 years
|
|
General disorders
Fever
|
8.6%
3/35 • Up to 2 years
|
|
Investigations
INR
|
8.6%
3/35 • Up to 2 years
|
|
Investigations
Lymphopenia
|
8.6%
3/35 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Up to 2 years
|
|
Investigations
Creatinine
|
5.7%
2/35 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Up to 2 years
|
|
Investigations
Leukocytes
|
5.7%
2/35 • Up to 2 years
|
|
Investigations
Lipase
|
5.7%
2/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain - scalp
|
5.7%
2/35 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain - skin
|
5.7%
2/35 • Up to 2 years
|
Additional Information
Dr. David Ilson, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4183
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place