Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Details
Study Description
Brief Summary
This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.
Detailed Description
PRIMARY OBJECTIVES:
- Assess the efficacy of adding erlotinib hydrochloride (erlotinib) to chemotherapy to improve progression free survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck.
SECONDARY OBJECTIVES:
-
Evaluate overall survival, response rate, disease control rate, and duration of response by treatment with or without erlotinib.
-
Evaluate quality of life (patient reported outcomes) by treatment with or without erlotinib.
-
Evaluate the safety profile of erlotinib in combination with chemotherapy. IV. Correlate the occurrence of erlotinib-induced rash with outcomes. V. To evaluate the steady-state pharmacokinetics of erlotinib. VI. To explore the prognostic and predictive value of epidermal growth factor receptor related biomarkers and other biomarkers, including blood and tissue proteomic and blood and tissue genomic markers, that may be associated with clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive docetaxel intravenously (IV) over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1, and erlotinib hydrochloride orally (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: 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.
After completion of study treatment, patients are followed up at 30 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Carboplatin
Given IV
Other Names:
Drug: Cisplatin
Given IV
Other Names:
Drug: Docetaxel
Given IV
Other Names:
Drug: Erlotinib Hydrochloride
Given PO
Other Names:
Other: Laboratory Biomarker Analysis
Optional correlative studies
Other: Pharmacological Study
Optional correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Active Comparator: 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. |
Drug: Carboplatin
Given IV
Other Names:
Drug: Cisplatin
Given IV
Other Names:
Drug: Docetaxel
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Optional correlative studies
Other: Pharmacological Study
Optional correlative studies
Other: Placebo
Given PO
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [5 years]
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.
Secondary Outcome Measures
- Overall Survival (OS) [5 years]
Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.
- Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR]) [5 years]
Per 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
- Disease Control (CR + PR + Stable Disease [SD]) [5 years]
Complete Response (CR) + Partial Response (PR) + Stable disease
- Rash Rates [5 years]
Participants with a Rash of at least grade 2 within cycle 1.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, hypopharynx or larynx; metastatic or recurrent lesions of the nasopharynx and sinus are excluded
-
Radiologically measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes are required to be >= 15 mm in size (short axis diameter)
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
-
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
-
Platelet count >= 100 x 10^9/L
-
Total bilirubin =< upper limit of normal (ULN) (excluding Gilbert's disease)
-
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x ULN
-
Alkaline phosphatase =< 2.5 x ULN
-
Serum creatinine =< 1.5 x ULN
-
Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< 14 days prior to treatment initiation
-
Written informed consent to participate in the study according to the investigational review board (IRB) or independent ethics committee (IEC)
Exclusion Criteria:
-
Histology other than squamous cell carcinoma
-
Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx
-
Prior palliative chemotherapy for metastatic or recurrent disease
-
Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization
-
Patients with known, untreated brain metastases; patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable
-
Pre-existing peripheral neuropathy >= grade 2
-
History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis); patients requiring feeding tubes are permitted
-
Other active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanoma
-
Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician
-
History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80
-
Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer
-
Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
-
Women who are pregnant or breast-feeding and women or men not practicing effective birth control
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 2 | MD Anderson Regional Care Center-Katy | Houston | Texas | United States | 77094 |
| 3 | MD Anderson Regional Care Center-Bay Area | Nassau Bay | Texas | United States | 77058 |
| 4 | MD Anderson Regional Care Center-Sugar Land | Sugar Land | Texas | United States | 77478 |
| 5 | MD Anderson Regional Care Center-The Woodlands | The Woodlands | Texas | United States | 77384 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Xiuning Le, M.D. Anderson Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2009-0395
- NCI-2011-03782
- 2009-0395
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail | 123 participants registered-4 participants were inevaluable (2 refused not due to toxicity, 2 other). |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 60 | 59 |
| COMPLETED | 45 | 42 |
| NOT COMPLETED | 15 | 17 |
Baseline Characteristics
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 60 | 59 | 119 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
52
86.7%
|
51
86.4%
|
103
86.6%
|
| >=65 years |
8
13.3%
|
8
13.6%
|
16
13.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
13
21.7%
|
14
23.7%
|
27
22.7%
|
| Male |
47
78.3%
|
45
76.3%
|
92
77.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
3.3%
|
1
1.7%
|
3
2.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
3.3%
|
4
6.8%
|
6
5%
|
| White |
51
85%
|
49
83.1%
|
100
84%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
5
8.3%
|
5
8.5%
|
10
8.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
60
100%
|
59
100%
|
119
100%
|
Outcome Measures
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | 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. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 60 | 59 |
| Median (95% Confidence Interval) [months] |
6.08
|
4.4
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 60 | 59 |
| Median (95% Confidence Interval) [months] |
16.95
|
13.67
|
| Title | Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR]) |
|---|---|
| Description | Per 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 |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 60 | 59 |
| Complete Response |
4
6.7%
|
5
8.5%
|
| Partial Response |
27
45%
|
19
32.2%
|
| Progressive Disease |
8
13.3%
|
13
22%
|
| Stable Disease |
16
26.7%
|
17
28.8%
|
| Inevaluable |
5
8.3%
|
5
8.5%
|
| Title | Disease Control (CR + PR + Stable Disease [SD]) |
|---|---|
| Description | Complete Response (CR) + Partial Response (PR) + Stable disease |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 60 | 59 |
| Count of Participants [Participants] |
47
78.3%
|
41
69.5%
|
| Title | Rash Rates |
|---|---|
| Description | Participants with a Rash of at least grade 2 within cycle 1. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 60 | 59 |
| Count of Participants [Participants] |
20
33.3%
|
4
6.8%
|
Adverse Events
| Time Frame | From the first dose through 30 days after the last does of study medication, up to 5 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | MedDRA v12 | |||
| Arm/Group Title | Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 37/60 (61.7%) | 53/59 (89.8%) | ||
Serious Adverse Events |
||||
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/60 (35%) | 46/59 (78%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 3/60 (5%) | 3/59 (5.1%) | ||
| Febrile neutropenia | 3/60 (5%) | 2/59 (3.4%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/60 (0%) | 1/59 (1.7%) | ||
| Myocardial infarction | 1/60 (1.7%) | 0/59 (0%) | ||
| Cardiac arrest | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Asystole | 1/60 (1.7%) | 0/59 (0%) | ||
| Heart failure | 1/60 (1.7%) | 0/59 (0%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 4/60 (6.7%) | 2/59 (3.4%) | ||
| Oral pain | 2/60 (3.3%) | 0/59 (0%) | ||
| Diarrhea | 5/60 (8.3%) | 1/59 (1.7%) | ||
| Dehydration | 8/60 (13.3%) | 5/59 (8.5%) | ||
| Dysphagia | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Abdominal pain | 3/60 (5%) | 1/59 (1.7%) | ||
| Vomiting | 2/60 (3.3%) | 1/59 (1.7%) | ||
| Duodenal hemorrhage | 3/60 (5%) | 0/59 (0%) | ||
| Mucositis oral | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Esophageal ulcer | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Gastric ulcer | 1/60 (1.7%) | 0/59 (0%) | ||
| Gastric hemorrhage | 1/60 (1.7%) | 0/59 (0%) | ||
| Pancreatitis | 2/60 (3.3%) | 0/59 (0%) | ||
| Oral cavity fistula | 0/60 (0%) | 1/59 (1.7%) | ||
| Upper gastrointestinal fistula | 0/60 (0%) | 1/59 (1.7%) | ||
| Duodenal ulcer | 0/60 (0%) | 1/59 (1.7%) | ||
| General disorders | ||||
| Fever | 2/60 (3.3%) | 0/59 (0%) | ||
| Edema limbs | 1/60 (1.7%) | 0/59 (0%) | ||
| Infections and infestations | ||||
| Lung infection | 7/60 (11.7%) | 5/59 (8.5%) | ||
| Skin infection | 1/60 (1.7%) | 0/59 (0%) | ||
| Abdominal infection | 1/60 (1.7%) | 0/59 (0%) | ||
| Urinary tract infection | 1/60 (1.7%) | 0/59 (0%) | ||
| Device related infection | 1/60 (1.7%) | 0/59 (0%) | ||
| Stoma site infection | 1/60 (1.7%) | 0/59 (0%) | ||
| Sepsis | 5/60 (8.3%) | 2/59 (3.4%) | ||
| Mucosal infection | 0/60 (0%) | 1/59 (1.7%) | ||
| Tracheitis | 1/60 (1.7%) | 0/59 (0%) | ||
| Wound infection | 0/60 (0%) | 1/59 (1.7%) | ||
| Soft tissue infection | 0/60 (0%) | 1/59 (1.7%) | ||
| Infections and infestations-other | 1/60 (1.7%) | 0/59 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Vascular access complication | 0/60 (0%) | 1/59 (1.7%) | ||
| Catheter related infection | 0/60 (0%) | 1/59 (1.7%) | ||
| Investigations | ||||
| Hyponatremia | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Hypokalemia | 1/60 (1.7%) | 0/59 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/60 (1.7%) | 0/59 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Pain | 0/60 (0%) | 1/59 (1.7%) | ||
| Neck pain | 0/60 (0%) | 1/59 (1.7%) | ||
| Osteonecrosis of jaw | 0/60 (0%) | 1/59 (1.7%) | ||
| Nervous system disorders | ||||
| Syncope | 2/60 (3.3%) | 0/59 (0%) | ||
| Stroke | 2/60 (3.3%) | 0/59 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 2/60 (3.3%) | 1/59 (1.7%) | ||
| Aspiration | 2/60 (3.3%) | 3/59 (5.1%) | ||
| Pharyngeal fistula | 1/60 (1.7%) | 0/59 (0%) | ||
| Respiratory failure | 1/60 (1.7%) | 1/59 (1.7%) | ||
| Productive cough | 1/60 (1.7%) | 0/59 (0%) | ||
| Pleural effusion | 1/60 (1.7%) | 0/59 (0%) | ||
| Laryngeal edema | 1/60 (1.7%) | 0/59 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 2/60 (3.3%) | 1/59 (1.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | Arm B (Combination Chemotherapy and Placebo) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 56/60 (93.3%) | 55/59 (93.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 13/60 (21.7%) | 4/59 (6.8%) | ||
| Eye disorders | ||||
| Watering eyes | 6/60 (10%) | 2/59 (3.4%) | ||
| Blurred vision | 2/60 (3.3%) | 3/59 (5.1%) | ||
| Eyelid function disorder | 3/60 (5%) | 1/59 (1.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 46/60 (76.7%) | 30/59 (50.8%) | ||
| Nausea | 38/60 (63.3%) | 27/59 (45.8%) | ||
| Mucositis oral | 16/60 (26.7%) | 17/59 (28.8%) | ||
| Vomiting | 23/60 (38.3%) | 10/59 (16.9%) | ||
| Abdominal pain | 5/60 (8.3%) | 5/59 (8.5%) | ||
| Oral pain | 11/60 (18.3%) | 12/59 (20.3%) | ||
| Constipation | 6/60 (10%) | 11/59 (18.6%) | ||
| Dyspepsia | 4/60 (6.7%) | 6/59 (10.2%) | ||
| Dysphagia | 4/60 (6.7%) | 3/59 (5.1%) | ||
| General disorders | ||||
| Fatigue | 40/60 (66.7%) | 33/59 (55.9%) | ||
| Edema face | 4/60 (6.7%) | 0/59 (0%) | ||
| Fever | 5/60 (8.3%) | 0/59 (0%) | ||
| Infections and infestations | ||||
| Lung infection | 3/60 (5%) | 2/59 (3.4%) | ||
| Mucosal infection | 0/60 (0%) | 4/59 (6.8%) | ||
| Paronychia | 4/60 (6.7%) | 1/59 (1.7%) | ||
| Skin infection | 2/60 (3.3%) | 4/59 (6.8%) | ||
| Investigations | ||||
| Weight loss | 10/60 (16.7%) | 3/59 (5.1%) | ||
| Hypomagnesemia | 4/60 (6.7%) | 2/59 (3.4%) | ||
| Blood bilirubin increase | 5/60 (8.3%) | 0/59 (0%) | ||
| Hypokalemia | 7/60 (11.7%) | 2/59 (3.4%) | ||
| Hyponatriema | 6/60 (10%) | 1/59 (1.7%) | ||
| Platelet count decreased | 3/60 (5%) | 0/59 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 10/60 (16.7%) | 4/59 (6.8%) | ||
| Anorexia | 14/60 (23.3%) | 7/59 (11.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Pain | 10/60 (16.7%) | 5/59 (8.5%) | ||
| Myalgia | 5/60 (8.3%) | 9/59 (15.3%) | ||
| Nervous system disorders | ||||
| Dizziness | 7/60 (11.7%) | 10/59 (16.9%) | ||
| Paresthesia | 1/60 (1.7%) | 3/59 (5.1%) | ||
| Peripheral sensory neuropathy | 4/60 (6.7%) | 2/59 (3.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 7/60 (11.7%) | 6/59 (10.2%) | ||
| Cough | 6/60 (10%) | 2/59 (3.4%) | ||
| Epistaxis | 3/60 (5%) | 1/59 (1.7%) | ||
| Productive cough | 3/60 (5%) | 2/59 (3.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash maculo-papular | 35/60 (58.3%) | 12/59 (20.3%) | ||
| Dry skin | 22/60 (36.7%) | 13/59 (22%) | ||
| Rash acneform | 31/60 (51.7%) | 10/59 (16.9%) | ||
| Alopecia | 9/60 (15%) | 12/59 (20.3%) | ||
| Nail discoloration | 6/60 (10%) | 4/59 (6.8%) | ||
| Pruritis | 4/60 (6.7%) | 4/59 (6.8%) | ||
| Nail ridging | 1/60 (1.7%) | 3/59 (5.1%) | ||
| Palmar-plantar erythrodysesthesia syndrom | 2/60 (3.3%) | 3/59 (5.1%) | ||
| Rash pustular | 3/60 (5%) | 1/59 (1.7%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Xiuning Le, MD, Assistant Professor, Thoracic-Head & Neck Med Onc |
|---|---|
| Organization | UT MD Anderson Cancer Center |
| Phone | (713) 792-6980 |
| xle1@mdanderson.org |
- 2009-0395
- NCI-2011-03782
- 2009-0395