Trial Outcomes & Findings for Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (NCT NCT01064479)
NCT ID: NCT01064479
Last Updated: 2024-07-16
Results Overview
Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
5 years
Results posted on
2024-07-16
Participant Flow
Patients with histologically confirmed metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx or larynx who have an ECOG performance status of 0-2, measurable disease and no prior chemotherapy for their metastatic or recurrent disease were enrolled
123 participants registered-4 participants were inevaluable (2 refused not due to toxicity, 2 other).
Participant milestones
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
45
|
42
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Overall Study
Death
|
10
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Disease progression
|
1
|
1
|
|
Overall Study
Toxicity
|
1
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsKaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
Outcome measures
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
6.08 months
Interval 5.45 to 7.52
|
4.4 months
Interval 3.45 to 5.78
|
SECONDARY outcome
Timeframe: 5 yearsKaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.
Outcome measures
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Overall Survival (OS)
|
16.95 months
Interval 10.12 to
below the level of detection
|
13.67 months
Interval 10.64 to 18.73
|
SECONDARY outcome
Timeframe: 5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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
Outcome measures
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
Complete Response
|
4 Participants
|
5 Participants
|
|
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
Partial Response
|
27 Participants
|
19 Participants
|
|
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
Progressive Disease
|
8 Participants
|
13 Participants
|
|
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
Stable Disease
|
16 Participants
|
17 Participants
|
|
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
Inevaluable
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 5 yearsComplete Response (CR) + Partial Response (PR) + Stable disease
Outcome measures
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Disease Control (CR + PR + Stable Disease [SD])
|
47 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 5 yearsParticipants with a Rash of at least grade 2 within cycle 1.
Outcome measures
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 Participants
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 Participants
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Rash Rates
|
20 Participants
|
4 Participants
|
Adverse Events
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
Serious events: 21 serious events
Other events: 56 other events
Deaths: 37 deaths
Arm B (Combination Chemotherapy and Placebo)
Serious events: 46 serious events
Other events: 55 other events
Deaths: 53 deaths
Serious adverse events
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 participants at risk
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 participants at risk
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Nervous system disorders
Syncope
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Vascular disorders
Hypotension
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Dehydration
|
13.3%
8/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
8.5%
5/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Lung infection
|
11.7%
7/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
8.5%
5/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Nervous system disorders
Stroke
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
General disorders
Fever
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Esophageal ulcer
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Abdominal infection
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Device related infection
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Stoma site infection
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Sepsis
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Injury, poisoning and procedural complications
Catheter related infection
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Cardiac disorders
Asystole
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Tracheitis
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
General disorders
Edema limbs
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Cardiac disorders
Heart failure
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Wound infection
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Upper gastrointestinal fistula
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Hyponatremia
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Hypokalemia
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Infections and infestations-other
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
Other adverse events
| Measure |
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
n=60 participants at risk
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
|
Arm B (Combination Chemotherapy and Placebo)
n=59 participants at risk
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
|
|---|---|---|
|
Eye disorders
Eyelid function disorder
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
General disorders
Fever
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Hypokalemia
|
11.7%
7/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Hyponatriema
|
10.0%
6/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Lung infection
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
10/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Diarrhea
|
76.7%
46/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
50.8%
30/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Blood and lymphatic system disorders
Anemia
|
21.7%
13/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Nausea
|
63.3%
38/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
45.8%
27/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
General disorders
Fatigue
|
66.7%
40/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
55.9%
33/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Mucositis oral
|
26.7%
16/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
28.8%
17/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
58.3%
35/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
20.3%
12/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
14/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
11.9%
7/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
36.7%
22/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
22.0%
13/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Musculoskeletal and connective tissue disorders
Pain
|
16.7%
10/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
8.5%
5/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
23/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
16.9%
10/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Rash acneform
|
51.7%
31/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
16.9%
10/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
8.5%
5/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Oral pain
|
18.3%
11/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
20.3%
12/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
9/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
20.3%
12/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Constipation
|
10.0%
6/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
18.6%
11/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Nervous system disorders
Dizziness
|
11.7%
7/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
16.9%
10/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Weight loss
|
16.7%
10/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
15.3%
9/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
10.0%
6/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.7%
7/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
10.2%
6/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Hypomagnesemia
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Eye disorders
Watering eyes
|
10.0%
6/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Blood bilirubin increase
|
8.3%
5/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Eye disorders
Blurred vision
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
6/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
10.2%
6/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
General disorders
Edema face
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrom
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Nervous system disorders
Paresthesia
|
1.7%
1/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
5.1%
3/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Paronychia
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
4/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Investigations
Platelet count decreased
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
0.00%
0/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
3.4%
2/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
5.0%
3/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
1.7%
1/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
|
Infections and infestations
Skin infection
|
3.3%
2/60 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
6.8%
4/59 • From the first dose through 30 days after the last does of study medication, up to 5 years
MedDRA v12
|
Additional Information
Dr. Xiuning Le, MD, Assistant Professor, Thoracic-Head & Neck Med Onc
UT MD Anderson Cancer Center
Phone: (713) 792-6980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place