Trial Outcomes & Findings for Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00550537)
NCT ID: NCT00550537
Last Updated: 2017-06-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
End of treatment date
Results posted on
2017-06-08
Participant Flow
The recruitment period for this trial was October 2007 to July 2011. Participants were recruited at Vanderbilt Medical Center, Emory University, M.D. Anderson Cancer Center, University of Florida - Gainesville.
10 participants were consented to participate in this trial, but were determined to be ineligible; 3 participants withdrew from the study prior to beginning treatment; 1 participant progressed before beginning treatment.
Participant milestones
| Measure |
Treatment
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
104
|
Reasons for withdrawal
| Measure |
Treatment
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|
|
Overall Study
Death
|
18
|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Disease progression before
|
46
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Change in treatment plan
|
4
|
|
Overall Study
Other complicating ilness
|
3
|
|
Overall Study
Declining performance status
|
2
|
|
Overall Study
Treated closer to home
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=116 Participants
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 11.3 • n=116 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=116 Participants
|
PRIMARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
End of treatment date
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of treatment datePopulation: Lab data was lost by the collaborating institution, Colorado.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Total 116 participants, 11 not assessed and 4 not evaluable. 101 assessed for response.
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response.
Outcome measures
| Measure |
Treatment
n=101 Participants
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib Followed by PC+B
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|---|---|
|
Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
|
18.8 percentage of patients assessed
Interval 12.4 to 27.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Total 116 participants. One patient was excluded due to death before erlotinib treatment. Total 115 patients were included in the analysis.
PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method.
Outcome measures
| Measure |
Treatment
n=115 Participants
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib Followed by PC+B
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|---|---|
|
Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
|
3.16 months
Interval 2.7 to 4.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: 116 paticipants, one patient was excluded due to death before any treatment. All patients who received erlotinib treatment and experienced an Adverse events.
The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) \[version 3.0 of December 2003\] (Appendix B). Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Treatment
n=115 Participants
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib Followed by PC+B
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|---|---|
|
Number of Patients With Worst-grade Toxicities Per Grade
worst-grade 1
|
18 participants
|
—
|
—
|
|
Number of Patients With Worst-grade Toxicities Per Grade
worst-grade 2
|
51 participants
|
—
|
—
|
|
Number of Patients With Worst-grade Toxicities Per Grade
worst-grade 3
|
15 participants
|
—
|
—
|
|
Number of Patients With Worst-grade Toxicities Per Grade
worst-grade 4
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Total 116 participants. One patient was excluded due to death before any treatment.
The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method.
Outcome measures
| Measure |
Treatment
n=30 Participants
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib Followed by PC+B
n=27 Participants
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
Erlotinib
n=58 Participants
Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|---|---|
|
Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
|
12.53 months
Interval 6.94 to 19.1
|
17.23 months
Interval 8.19 to 30.2
|
6.08 months
Interval 3.98 to 12.3
|
Adverse Events
Treatment
Serious events: 8 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=116 participants at risk
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|
|
Infections and infestations
Infection (urinary tract)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Infections and infestations
Infection (pharynx)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Rash (allergy)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Infections and infestations
Infection (port)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (other)
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
iatrogenic pneumothorax
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
worsening pneumothorax and subcutaneous emphysema.
|
0.86%
1/116 • Number of events 1 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
Other adverse events
| Measure |
Treatment
n=116 participants at risk
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.9%
59/116 • Number of events 96 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Nausea
|
36.2%
42/116 • Number of events 69 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.4%
33/116 • Number of events 43 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
General disorders
Constipation
|
25.0%
29/116 • Number of events 39 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
21.6%
25/116 • Number of events 26 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Vomiting
|
15.5%
18/116 • Number of events 25 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Mucositis
|
12.9%
15/116 • Number of events 17 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Heartburn
|
11.2%
13/116 • Number of events 16 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Rash (acne/acneiform)
|
47.4%
55/116 • Number of events 94 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Rash (desquamation)
|
34.5%
40/116 • Number of events 76 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.7%
31/116 • Number of events 35 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.9%
30/116 • Number of events 35 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (other)
|
18.1%
21/116 • Number of events 35 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.8%
16/116 • Number of events 20 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Fatigue
|
51.7%
60/116 • Number of events 105 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Eye disorders
Weight loss
|
19.0%
22/116 • Number of events 23 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
General disorders
Chills
|
8.6%
10/116 • Number of events 10 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
20.7%
24/116 • Number of events 35 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
19/116 • Number of events 27 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
16.4%
19/116 • Number of events 25 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Nervous system disorders
Headache
|
12.9%
15/116 • Number of events 17 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Check pain
|
12.1%
14/116 • Number of events 18 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
12/116 • Number of events 18 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
30.2%
35/116 • Number of events 54 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
31/116 • Number of events 43 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
10.3%
12/116 • Number of events 14 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (other)
|
8.6%
10/116 • Number of events 16 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.7%
31/116 • Number of events 59 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
27/116 • Number of events 51 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Serum glutamic pyruvic transaminase
|
19.8%
23/116 • Number of events 41 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Alkaline phosphase
|
19.0%
22/116 • Number of events 30 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
10.3%
12/116 • Number of events 37 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Bilirubin
|
14.7%
17/116 • Number of events 21 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Magnesium, serum low
|
12.1%
14/116 • Number of events 22 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Albumin, serum low
|
9.5%
11/116 • Number of events 15 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Metabolism and nutrition disorders
Potassium, serum low
|
9.5%
11/116 • Number of events 19 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Nervous system disorders
Sensory alteration
|
21.6%
25/116 • Number of events 38 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Nervous system disorders
Dizziness
|
11.2%
13/116 • Number of events 14 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Psychiatric disorders
Mood alteration, depression
|
10.3%
12/116 • Number of events 15 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Psychiatric disorders
Anxiety
|
7.8%
9/116 • Number of events 9 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
29.3%
34/116 • Number of events 59 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Blood and lymphatic system disorders
Leukocytes
|
9.5%
11/116 • Number of events 19 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Blood and lymphatic system disorders
Platelets
|
8.6%
10/116 • Number of events 12 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Eye disorders
Visual alteration
|
9.5%
11/116 • Number of events 14 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Eye disorders
Dry eye syndrome
|
8.6%
10/116 • Number of events 10 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, nose
|
11.2%
13/116 • Number of events 19 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
General disorders
Edema, limb
|
13.8%
16/116 • Number of events 19 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
11.2%
13/116 • Number of events 15 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
|
Cardiac disorders
Hypertension
|
9.5%
11/116 • Number of events 17 • Patients were 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. After discontinuation from treatment, patients are followed up for all existing and new AEs for 30 calendar days after the last dose of study drug. All new AEs occurring during that period are recorded and followed to resolution when possible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place