Trial Outcomes & Findings for Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer (NCT NCT00054275)
NCT ID: NCT00054275
Last Updated: 2016-02-17
Results Overview
Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
after 6 course (6 months) of combination therapy
Results posted on
2016-02-17
Participant Flow
Patients recruited from University Hospitals and its satellite hospitals from 12/4/2002 through 9/22/2006.
Participant milestones
| Measure |
Docetaxel and OSI-774
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Docetaxel and OSI-774
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Progressive disease in cycle 1
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel and OSI-774
n=39 Participants
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 6 course (6 months) of combination therapyPopulation: Excluding 11 not evaluable cases
Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
Outcome measures
| Measure |
Docetaxel and OSI-774
n=28 Participants
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
Partial response
|
11 participants
Interval 0.23 to 0.58
|
|
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
Disease progression
|
14 participants
|
|
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
Stable disease
|
3 participants
|
SECONDARY outcome
Timeframe: 3 yearsProgression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Docetaxel and OSI-774
n=39 Participants
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Progression Free Survival(PFS)
|
8.4 months
Interval 4.8 to 12.8
|
SECONDARY outcome
Timeframe: 5 yrsPopulation: Including 10 patients with only 1 cycle of treatment
Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.
Outcome measures
| Measure |
Docetaxel and OSI-774
n=39 Participants
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Overall Survival as of 2008
|
22.3 months
Interval 15.2 to 30.6
|
Adverse Events
Docetaxel and OSI-774
Serious events: 28 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel and OSI-774
n=39 participants at risk
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.8%
5/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Cerebrovascular Ischemia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Cardiac disorders
Chest Pain
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Eye disorders
Eye tearing
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Fatigue
|
15.4%
6/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Hyperbilirubinbemia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Hyperbilirubinemia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Vascular disorders
Hypotension
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Infections and infestations
Infection
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Light headedness
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Lymphopenia
|
35.9%
14/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Mucositis
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Cardiac disorders
Pericarditis
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
SGOT (AST)
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
SGPT (ALT)
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Cardiac disorders
Sinus Tach.
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Taste Change(dysgeusia)
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Reproductive system and breast disorders
Vaginitis
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
Other adverse events
| Measure |
Docetaxel and OSI-774
n=39 participants at risk
docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Infection
|
20.5%
8/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Injection site reaction
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Psychiatric disorders
Insomnia
|
38.5%
15/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Leg edema
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Leukopenia
|
59.0%
23/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Alkaline Phosphatase
|
35.9%
14/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
61.5%
24/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Anemia
|
71.8%
28/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Anorexia
|
71.8%
28/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Psychiatric disorders
Anxiety
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
23.1%
9/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Bilirubin
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Eye disorders
Blurred Vision
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Eye disorders
Conjunctivitis
|
12.8%
5/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
12/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
15/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Psychiatric disorders
Depression
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Derm
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
27/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Eye disorders
Dry eye
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Dysgeusia
|
46.2%
18/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.8%
12/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Edema
|
15.4%
6/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Emesis
|
23.1%
9/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
41.0%
16/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Fatigue
|
94.9%
37/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Fever
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Vascular disorders
Flushing
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Renal and urinary disorders
Frequent urination
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot syndrome
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Headache
|
12.8%
5/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Vascular disorders
Hot Flashes
|
43.6%
17/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Hyperbilirubinemia
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
13/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
43.6%
17/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
38.5%
15/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Light headedness
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Vascular disorders
Lymphedema
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Lymphopenia
|
61.5%
24/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Mucositis
|
56.4%
22/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
25.6%
10/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Nausea
|
69.2%
27/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Neuropathy
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.5%
15/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Odynophagia
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Pain
|
28.2%
11/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.8%
5/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
3/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Skin and subcutaneous tissue disorders
Rash
|
69.2%
27/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Reflux
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
General disorders
Rigors or chills
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
SGOT (AST)
|
46.2%
18/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
SGPT (ALT)
|
43.6%
17/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Nervous system disorders
Sensory Neuropathy
|
33.3%
13/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Gastrointestinal disorders
Stomatitis
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
10.3%
4/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Eye disorders
Tearing
|
38.5%
15/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.9%
7/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Reproductive system and breast disorders
Vaginitis
|
5.1%
2/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
|
Investigations
Weight Loss
|
43.6%
17/39 • Patients will be evaluated for adverse events at each study visit for the duration of their participation in the study and for 30 days after the discontinuation of Tarceva.
|
Additional Information
Paula Silverman, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-3951
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place