Trial Outcomes & Findings for Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas (NCT NCT00532441)
NCT ID: NCT00532441
Last Updated: 2016-02-12
Results Overview
To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Start of treatment until disease progression per RECIST criteria up to 16 weeks
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
Hepatocellular
erlotinib and docetaxel
|
Biliary
erlotinib and docetaxel
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Hepatocellular
erlotinib and docetaxel
|
Biliary
erlotinib and docetaxel
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
Baseline characteristics by cohort
| Measure |
Erlotinib and Docetaxel
n=25 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|
|
Age, Customized
Age
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 0
|
11 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 1
|
12 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 2
|
2 participants
n=5 Participants
|
|
Cancer Type or Histologic Subtype
Biliary
|
11 participants
n=5 Participants
|
|
Cancer Type or Histologic Subtype
Hepatocellular
|
14 participants
n=5 Participants
|
|
Biliary Cancer Site
Cholangiocarcoma
|
6 participants
n=5 Participants
|
|
Biliary Cancer Site
Gallbladder
|
5 participants
n=5 Participants
|
|
Biliary Cancer Site
N/A
|
14 participants
n=5 Participants
|
|
Disease Status
Locally Advanced: Biliary
|
0 participants
n=5 Participants
|
|
Disease Status
Locally Advanced: Hepatocellular
|
4 participants
n=5 Participants
|
|
Disease Status
Metastatic: Biliary
|
11 participants
n=5 Participants
|
|
Disease Status
Metastatic: Hepatocellular
|
10 participants
n=5 Participants
|
|
Previous Treatment
Biliary: Chemotherapy
|
7 participants
n=5 Participants
|
|
Previous Treatment
Biliary: Targeted therapy (sorafenib)
|
0 participants
n=5 Participants
|
|
Previous Treatment
Biliary: Radiotherapy
|
3 participants
n=5 Participants
|
|
Previous Treatment
Biliary: Y90 Radioembolization
|
0 participants
n=5 Participants
|
|
Previous Treatment
Biliary: Surgery
|
2 participants
n=5 Participants
|
|
Previous Treatment
Hepatocellular: Chemotherapy
|
3 participants
n=5 Participants
|
|
Previous Treatment
Hepatocellular:Targeted therapy (sorafenib)
|
7 participants
n=5 Participants
|
|
Previous Treatment
Hepatocellular:Radiotherapy
|
2 participants
n=5 Participants
|
|
Previous Treatment
Hepatocellular: Y90 Radioembolization
|
2 participants
n=5 Participants
|
|
Previous Treatment
Hepatocellular:Surgery
|
3 participants
n=5 Participants
|
|
Number of Prior Systemic Therapies
Biliary: 1 Prior therapy
|
6 participants
n=5 Participants
|
|
Number of Prior Systemic Therapies
Biliary: >1 Prior Therapy
|
1 participants
n=5 Participants
|
|
Number of Prior Systemic Therapies
Hepatocellular: 1 Prior Therapy
|
6 participants
n=5 Participants
|
|
Number of Prior Systemic Therapies
Hepatocellular: >1 Prior Therapy
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment until disease progression per RECIST criteria up to 16 weeksTo determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Biliary
n=11 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
Hepatocellular
n=14 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|---|
|
16 Weeks Progression-free Survival
|
4.7 months
Interval 1.6 to 6.9
|
3.5 months
Interval 1.7 to 4.5
|
SECONDARY outcome
Timeframe: 18 monthsDetermine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Outcome measures
| Measure |
Biliary
n=11 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
Hepatocellular
n=13 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|---|
|
Response Rate
Complete Response or Partial Response
|
0 participants
|
0 participants
|
|
Response Rate
Stable Disease
|
7 participants
|
6 participants
|
|
Response Rate
Progressive Disease
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 18 MonthsDetermine Overall Survival
Outcome measures
| Measure |
Biliary
n=13 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
Hepatocellular
n=11 Participants
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|---|
|
Overall Survival
|
6.7 months
Interval 4.6 to 13.8
|
5.7 months
Interval 3.6 to 21.5
|
Adverse Events
Erlotinib and Docetaxel
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib and Docetaxel
n=25 participants at risk
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DEATH NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
4.0%
1/25 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / LOWER GI NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / CATHETER-RELATED
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Hepatobiliary disorders
LIVER DYSFUNCTION/FAILURE (CLINICAL)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Erlotinib and Docetaxel
n=25 participants at risk
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
12.0%
3/25 • Number of events 6 • 16 weeks
|
|
Investigations
ALKALINE PHOSPHATASE
|
40.0%
10/25 • Number of events 16 • 16 weeks
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
32.0%
8/25 • Number of events 12 • 16 weeks
|
|
Gastrointestinal disorders
ANOREXIA
|
44.0%
11/25 • Number of events 21 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
32.0%
8/25 • Number of events 12 • 16 weeks
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
20.0%
5/25 • Number of events 6 • 16 weeks
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
CONFUSION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
40.0%
10/25 • Number of events 22 • 16 weeks
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
36.0%
9/25 • Number of events 12 • 16 weeks
|
|
Investigations
CREATININE
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME/ACUTE INFUSION REACTION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
DEHYDRATION
|
16.0%
4/25 • Number of events 4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
24.0%
6/25 • Number of events 7 • 16 weeks
|
|
Gastrointestinal disorders
DIARRHEA
|
60.0%
15/25 • Number of events 24 • 16 weeks
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
DIZZINESS
|
24.0%
6/25 • Number of events 11 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
28.0%
7/25 • Number of events 11 • 16 weeks
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
32.0%
8/25 • Number of events 10 • 16 weeks
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
|
4.0%
1/25 • Number of events 2 • 16 weeks
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
76.0%
19/25 • Number of events 35 • 16 weeks
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
24.0%
6/25 • Number of events 9 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
FISTULA, PULMONARY/UPPER RESPIRATORY / BRONCHUS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
FLATULENCE
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
12.0%
3/25 • Number of events 3 • 16 weeks
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
28.0%
7/25 • Number of events 13 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
44.0%
11/25 • Number of events 12 • 16 weeks
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
16.0%
4/25 • Number of events 4 • 16 weeks
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
24.0%
6/25 • Number of events 10 • 16 weeks
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
4.0%
1/25 • Number of events 9 • 16 weeks
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / RECTUM
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
HYPERTENSION
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Cardiac disorders
HYPOTENSION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
INCONTINENCE, ANAL
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
INCONTINENCE, URINARY
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / CONJUNCTIVA
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
INSOMNIA
|
20.0%
5/25 • Number of events 5 • 16 weeks
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
16.0%
4/25 • Number of events 4 • 16 weeks
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
12.0%
3/25 • Number of events 3 • 16 weeks
|
|
Investigations
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 3 • 16 weeks
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
20.0%
5/25 • Number of events 5 • 16 weeks
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
32.0%
8/25 • Number of events 13 • 16 weeks
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
12.0%
3/25 • Number of events 4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
56.0%
14/25 • Number of events 22 • 16 weeks
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
28.0%
7/25 • Number of events 9 • 16 weeks
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
44.0%
11/25 • Number of events 14 • 16 weeks
|
|
General disorders
PAIN / BACK
|
12.0%
3/25 • Number of events 5 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
12.0%
3/25 • Number of events 3 • 16 weeks
|
|
General disorders
PAIN / BUTTOCK
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
PAIN / ESOPHAGUS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
16.0%
4/25 • Number of events 5 • 16 weeks
|
|
Hepatobiliary disorders
PAIN / GALLBLADDER
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
PAIN / HEAD/HEADACHE
|
12.0%
3/25 • Number of events 4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Hepatobiliary disorders
PAIN / LIVER
|
4.0%
1/25 • Number of events 2 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
4.0%
1/25 • Number of events 2 • 16 weeks
|
|
General disorders
PAIN / SINUS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Blood and lymphatic system disorders
PLATELETS
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
8.0%
2/25 • Number of events 4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
12.0%
3/25 • Number of events 4 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
36.0%
9/25 • Number of events 15 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
44.0%
11/25 • Number of events 16 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / RADIATION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
RIGORS/CHILLS
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
8.0%
2/25 • Number of events 4 • 16 weeks
|
|
Gastrointestinal disorders
STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI / DUODENUM
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
General disorders
SWEATING (DIAPHORESIS)
|
8.0%
2/25 • Number of events 3 • 16 weeks
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
40.0%
10/25 • Number of events 15 • 16 weeks
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
4.0%
1/25 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
VOMITING
|
36.0%
9/25 • Number of events 11 • 16 weeks
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
16.0%
4/25 • Number of events 4 • 16 weeks
|
|
General disorders
WEIGHT GAIN
|
4.0%
1/25 • Number of events 2 • 16 weeks
|
|
General disorders
WEIGHT LOSS
|
20.0%
5/25 • Number of events 6 • 16 weeks
|
Additional Information
Dr. EG Chiorean, MS
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place