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Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00086957
Recruitment Status : Completed
First Posted : July 12, 2004
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: trastuzumab
Drug: docetaxel
Drug: gefitinib
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I - Docetaxel 75 mg/m^2 Phase I - Docetaxel 60 mg/m^2 Phase II - Docetaxel 60 mg/m^2
Hide Arm/Group Description Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks. Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
Period Title: Overall Study
Started 2 7 22
Completed 2 7 22
Not Completed 0 0 0
Arm/Group Title Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2
Hide Arm/Group Description

trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.

docetaxel: 75 mg/m^2 every three weeks, or 60 mg/m^2 every three weeks depending on study findings

gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
52
(34 to 67)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Number of Participants With at Least One Dose Limiting Toxicity in Phase I
Hide Description Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.
Time Frame 4 weeks from start of treatment, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving treatment were evaluated for DLT.
Arm/Group Title Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 Phase I: Dose Level 2 - Docetaxel 60 mg/m^2
Hide Arm/Group Description:
Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
Overall Number of Participants Analyzed 2 7
Measure Type: Number
Unit of Measure: participants with DLTs
2 0
2.Primary Outcome
Title Recommended Phase II Dose
Hide Description The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.
Time Frame 4 weeks from start of treatment, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.
Arm/Group Title Phase I
Hide Arm/Group Description:
All patients enrolled on the Phase I (dose-finding) portion of the study.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg/m^2
60
3.Secondary Outcome
Title Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
Time Frame Until disease progression, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).
Arm/Group Title Dose Level 2 - Docetaxel 60 mg/m^2
Hide Arm/Group Description:
Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m2 intravenously every 3 weeks.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: Months
12.7
(7.6 to 21.8)
4.Secondary Outcome
Title Objective Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 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; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.
Time Frame After 3 cycles of treatment, up to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.
Arm/Group Title Dose Level 2 - Docetaxel 60 mg/m^2
Hide Arm/Group Description:
Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
64
5.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier.
Time Frame Until death from any cause, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).
Arm/Group Title Dose Level 2 - Docetaxel 60 mg/m^2
Hide Arm/Group Description:
Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: Months
43.2
(30.8 to 65.3)
Time Frame Adverse events occurred over a period of 5 years and 3 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Dose Level 1 - Docetaxel 75 mg/m^2 Dose Level 2 - Docetaxel 60 mg/m^2
Hide Arm/Group Description Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
All-Cause Mortality
Dose Level 1 - Docetaxel 75 mg/m^2 Dose Level 2 - Docetaxel 60 mg/m^2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dose Level 1 - Docetaxel 75 mg/m^2 Dose Level 2 - Docetaxel 60 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      7/29 (24.14%)    
Blood and lymphatic system disorders     
Febrile neutropenia * 1  2/2 (100.00%)  2 1/29 (3.45%)  1
Haemorrhage NOS * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Gastrointestinal disorders     
Abdominal pain * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Diarrhea * 1  0/2 (0.00%)  0 2/29 (6.90%)  2
Melaena * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Mucositis oral * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Nausea * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Vomiting * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations     
Catheter related infection * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Infection NOS * 1  0/2 (0.00%)  0 2/29 (6.90%)  2
Investigations     
Leukopenia * 1  1/2 (50.00%)  1 0/29 (0.00%)  0
Neutrophil count decreased * 1  1/2 (50.00%)  1 0/29 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Dehydration * 1  0/2 (0.00%)  0 2/29 (6.90%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal disorder * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 - Docetaxel 75 mg/m^2 Dose Level 2 - Docetaxel 60 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      29/29 (100.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Hemoglobin decreased * 1  2/2 (100.00%)  9 25/29 (86.21%)  196
Lymphatic disorder * 2  0/2 (0.00%)  0 9/29 (31.03%)  18
Packed red blood cell transfusion * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Cardiac disorders     
Arrhythmia * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Atrial fibrillation * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Cardiac disorder * 1  0/2 (0.00%)  0 2/29 (6.90%)  3
Left ventricular failure * 1  1/2 (50.00%)  1 5/29 (17.24%)  8
Myocardial ischemia * 1  0/2 (0.00%)  0 3/29 (10.34%)  3
Palpitations * 2  0/2 (0.00%)  0 1/29 (3.45%)  2
Sinus bradycardia * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Sinus tachycardia * 1  2/2 (100.00%)  3 8/29 (27.59%)  24
Ear and labyrinth disorders     
Ear disorder * 2  0/2 (0.00%)  0 1/29 (3.45%)  3
Ear pain * 1  1/2 (50.00%)  2 3/29 (10.34%)  4
External ear inflammation * 1  1/2 (50.00%)  1 1/29 (3.45%)  1
Hearing loss * 1  1/2 (50.00%)  2 1/29 (3.45%)  1
Endocrine disorders     
Hypothyroidism * 1  1/2 (50.00%)  1 0/29 (0.00%)  0
Eye disorders     
Dry eye syndrome * 2  0/2 (0.00%)  0 2/29 (6.90%)  2
Eye disorder * 1  0/2 (0.00%)  0 4/29 (13.79%)  7
Vision blurred * 1  1/2 (50.00%)  1 1/29 (3.45%)  1
Watering eyes * 2  0/2 (0.00%)  0 3/29 (10.34%)  4
Gastrointestinal disorders     
Haematemesis * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Abdominal pain * 2  0/2 (0.00%)  0 8/29 (27.59%)  18
Constipation * 1  1/2 (50.00%)  1 6/29 (20.69%)  16
Diarrhea * 1  2/2 (100.00%)  5 26/29 (89.66%)  129
Dry mouth * 1  1/2 (50.00%)  1 2/29 (6.90%)  2
Dyspepsia * 1  0/2 (0.00%)  0 3/29 (10.34%)  9
Dysphagia * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Esophagitis * 1  1/2 (50.00%)  1 0/29 (0.00%)  0
Gastritis * 2  0/2 (0.00%)  0 3/29 (10.34%)  4
Gastrointestinal disorder * 1  1/2 (50.00%)  2 9/29 (31.03%)  44
Melaena * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Mucositis oral * 1  2/2 (100.00%)  4 15/29 (51.72%)  32
Nausea * 1  2/2 (100.00%)  5 18/29 (62.07%)  44
 * 1  0/2 (0.00%)  0 2/29 (6.90%)  8
Rectal bleeding/hematochezia * 2  0/2 (0.00%)  0 2/29 (6.90%)  4
Vomiting * 1  0/2 (0.00%)  0 11/29 (37.93%)  17
General disorders     
Chest pain * 1  1/2 (50.00%)  1 3/29 (10.34%)  10
Chills * 1  2/2 (100.00%)  3 8/29 (27.59%)  12
Edema * 2  0/2 (0.00%)  0 2/29 (6.90%)  3
Fatigue * 1  2/2 (100.00%)  3 28/29 (96.55%)  158
Fever * 1  0/2 (0.00%)  0 11/29 (37.93%)  17
General symptom * 2  0/2 (0.00%)  0 3/29 (10.34%)  5
Injection site reaction * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Oedema NOS * 1  2/2 (100.00%)  5 6/29 (20.69%)  9
Pain * 1  2/2 (100.00%)  5 16/29 (55.17%)  60
Hepatobiliary disorders     
Hepatobiliary disease * 2  0/2 (0.00%)  0 1/29 (3.45%)  2
Immune system disorders     
Hypersensitivity * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Immune system disorder * 2  0/2 (0.00%)  0 3/29 (10.34%)  4
Infections and infestations     
Infection * 1  1/2 (50.00%)  2 5/29 (17.24%)  7
Infection NOS * 1  1/2 (50.00%)  2 9/29 (31.03%)  15
Infection with unknown ANC * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Infection without neutropenia * 2  0/2 (0.00%)  0 3/29 (10.34%)  3
Infection, Viral (COH) * 3  0/2 (0.00%)  0 1/29 (3.45%)  1
Wound infection * 1  1/2 (50.00%)  1 1/29 (3.45%)  3
Injury, poisoning and procedural complications     
Bruising * 2  0/2 (0.00%)  0 2/29 (6.90%)  2
Intraoperative gastrointestinal injury - Teeth * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Investigations     
Activated partial thromboplastin time prolonged * 1  0/2 (0.00%)  0 6/29 (20.69%)  45
Alanine aminotransferase increased * 1  1/2 (50.00%)  2 25/29 (86.21%)  97
Alkaline phosphatase increased * 1  1/2 (50.00%)  1 14/29 (48.28%)  30
Amylase increased * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Aspartate aminotransferase increased * 1  2/2 (100.00%)  5 25/29 (86.21%)  150
Bilirubin increased * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Creatinine increased * 1  0/2 (0.00%)  0 4/29 (13.79%)  4
Hyperbilirubinemia * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Hypercholesterolemia * 1  1/2 (50.00%)  3 1/29 (3.45%)  1
INR increased * 1  2/2 (100.00%)  4 14/29 (48.28%)  92
Laboratory test abnormal * 2  0/2 (0.00%)  0 9/29 (31.03%)  26
Leukocyte count decreased * 2  0/2 (0.00%)  0 12/29 (41.38%)  65
Leukopenia * 1  2/2 (100.00%)  6 16/29 (55.17%)  103
Lymphocyte count decreased * 2  0/2 (0.00%)  0 13/29 (44.83%)  93
Lymphopenia * 1  2/2 (100.00%)  5 12/29 (41.38%)  107
Neutrophil count decreased * 1  2/2 (100.00%)  4 24/29 (82.76%)  142
Platelet count decreased * 1  1/2 (50.00%)  1 5/29 (17.24%)  5
Weight gain * 1  1/2 (50.00%)  2 7/29 (24.14%)  26
Weight loss * 1  1/2 (50.00%)  3 9/29 (31.03%)  20
Metabolism and nutrition disorders     
Acidosis * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Anorexia * 1  1/2 (50.00%)  1 8/29 (27.59%)  15
Blood bicarbonate decreased * 1  1/2 (50.00%)  1 5/29 (17.24%)  6
Blood glucose increased * 2  0/2 (0.00%)  0 11/29 (37.93%)  42
Blood uric acid increased * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Dehydration * 1  1/2 (50.00%)  1 3/29 (10.34%)  3
Hypercalcemia * 1  0/2 (0.00%)  0 5/29 (17.24%)  8
Hyperglycemia * 1  1/2 (50.00%)  1 13/29 (44.83%)  53
Hyperkalemia * 1  0/2 (0.00%)  0 2/29 (6.90%)  2
Hypertriglyceridemia * 1  1/2 (50.00%)  1 1/29 (3.45%)  1
Hyperuricemia * 1  0/2 (0.00%)  0 4/29 (13.79%)  7
Hypoalbuminemia * 1  2/2 (100.00%)  4 13/29 (44.83%)  55
Hypocalcemia * 1  2/2 (100.00%)  5 11/29 (37.93%)  30
Hypoglycemia * 1  0/2 (0.00%)  0 3/29 (10.34%)  4
Hypokalemia * 1  2/2 (100.00%)  2 10/29 (34.48%)  29
Hypomagnesemia * 1  0/2 (0.00%)  0 9/29 (31.03%)  22
Hyponatremia * 1  1/2 (50.00%)  1 5/29 (17.24%)  5
Hypophosphatemia * 1  2/2 (100.00%)  2 14/29 (48.28%)  54
Serum albumin decreased * 2  0/2 (0.00%)  0 8/29 (27.59%)  25
Serum calcium decreased * 2  0/2 (0.00%)  0 6/29 (20.69%)  8
Serum calcium increased * 2  0/2 (0.00%)  0 3/29 (10.34%)  8
Serum glucose decreased * 2  0/2 (0.00%)  0 2/29 (6.90%)  2
Serum magnesium decreased * 2  0/2 (0.00%)  0 7/29 (24.14%)  25
Serum magnesium increased * 2  0/2 (0.00%)  0 2/29 (6.90%)  2
Serum phosphate decreased * 2  0/2 (0.00%)  0 6/29 (20.69%)  15
Serum potassium decreased * 2  0/2 (0.00%)  0 10/29 (34.48%)  23
Serum sodium decreased * 2  0/2 (0.00%)  0 2/29 (6.90%)  3
Musculoskeletal and connective tissue disorders     
Bone pain * 1  1/2 (50.00%)  1 8/29 (27.59%)  19
Joint pain * 2  0/2 (0.00%)  0 4/29 (13.79%)  4
Muscle weakness * 1  0/2 (0.00%)  0 5/29 (17.24%)  5
Musculoskeletal disorder * 1  1/2 (50.00%)  1 8/29 (27.59%)  12
Myalgia * 2  0/2 (0.00%)  0 5/29 (17.24%)  16
Pain in extremity * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders     
Ataxia * 1  1/2 (50.00%)  1 0/29 (0.00%)  0
Dizziness * 1  2/2 (100.00%)  2 5/29 (17.24%)  10
Headache * 1  1/2 (50.00%)  2 10/29 (34.48%)  22
Neuralgia * 2  0/2 (0.00%)  0 5/29 (17.24%)  7
Neurological disorder NOS * 2  0/2 (0.00%)  0 6/29 (20.69%)  7
Peripheral motor neuropathy * 1  0/2 (0.00%)  0 2/29 (6.90%)  2
Peripheral sensory neuropathy * 1  0/2 (0.00%)  0 9/29 (31.03%)  26
Syncope * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Taste alteration * 2  0/2 (0.00%)  0 8/29 (27.59%)  11
Psychiatric disorders     
Anxiety * 1  0/2 (0.00%)  0 10/29 (34.48%)  13
Depression * 1  0/2 (0.00%)  0 7/29 (24.14%)  9
Insomnia * 1  0/2 (0.00%)  0 1/29 (3.45%)  2
Personality change * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders     
Bladder pain * 1  1/2 (50.00%)  1 5/29 (17.24%)  6
Protein urine positive * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Urinary frequency * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Urinary retention * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Urine discoloration * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
Urogenital disorder * 2  0/2 (0.00%)  0 3/29 (10.34%)  3
Reproductive system and breast disorders     
Reproductive tract disorder * 2  0/2 (0.00%)  0 1/29 (3.45%)  3
Vaginal dryness * 2  0/2 (0.00%)  0 1/29 (3.45%)  2
Vaginal hemorrhage * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Vaginal inflammation * 1  0/2 (0.00%)  0 2/29 (6.90%)  3
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis * 1  1/2 (50.00%)  1 4/29 (13.79%)  6
Cough * 1  2/2 (100.00%)  3 12/29 (41.38%)  36
Dyspnea * 1  1/2 (50.00%)  2 12/29 (41.38%)  27
Hemorrhage nasal * 2  0/2 (0.00%)  0 4/29 (13.79%)  5
Hypoxia * 1  1/2 (50.00%)  1 1/29 (3.45%)  1
Pneumonitis * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Pneumothorax * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Respiratory disorder * 2  0/2 (0.00%)  0 9/29 (31.03%)  21
Voice alteration * 1  1/2 (50.00%)  2 4/29 (13.79%)  6
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/2 (0.00%)  0 9/29 (31.03%)  24
Dry skin * 1  0/2 (0.00%)  0 11/29 (37.93%)  16
Nail disorder * 1  0/2 (0.00%)  0 7/29 (24.14%)  15
Pigmentation changes (e.g., vitiligo) * 2  0/2 (0.00%)  0 2/29 (6.90%)  2
Pruritus * 1  1/2 (50.00%)  2 9/29 (31.03%)  9
Rash desquamating * 1  2/2 (100.00%)  5 24/29 (82.76%)  77
Skin discolouration * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Skin disorder * 1  1/2 (50.00%)  1 12/29 (41.38%)  30
Urticaria * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Vascular disorders     
Flushing * 1  1/2 (50.00%)  2 4/29 (13.79%)  9
Hemorrhage * 1  0/2 (0.00%)  0 1/29 (3.45%)  1
Hot flashes * 2  0/2 (0.00%)  0 2/29 (6.90%)  3
Hypertension * 1  1/2 (50.00%)  5 3/29 (10.34%)  4
Hypotension * 1  1/2 (50.00%)  1 7/29 (24.14%)  8
Thrombosis * 2  0/2 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
3
Term from vocabulary, COH
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-359-8111 ext 65265
EMail: pfrankel@coh.org
Publications of Results:
Somlo G, Koczywas M, Luu T, et al.: A phase I-II study of trastuzumab, gefitinib, and docetaxel as first line chemotherapy in patients with HER-2 overexpressing stage IV breast carcinoma. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2035, 2005.
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00086957    
Other Study ID Numbers: 03049
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-03049
ZENECA-1839US/0274
ZENECA-IRUSIRES0012
CDR0000371908 ( Registry Identifier: NCI PDQ )
First Submitted: July 8, 2004
First Posted: July 12, 2004
Results First Submitted: November 4, 2016
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017