Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00553462
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 78
• Locations: 99
• Arm: 1
• Duration (Months): 111.5
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To determine the activity of induction chemotherapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage IIIA or IIIB non-small cell lung cancer.

Secondary

• To determine the response rate and progression-free survival of these patients.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jun 15, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: paclitaxel + carboplatin + radiation + erlotinib Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

1. Overall Survival at 12 Months [At 12 months]

   Percentage of participants who were alive at 12 months.

Secondary Outcome Measures

1. Response Rate [Duration of study (up to 2 years)]

   Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Response rate is reported as the percentage of participants who achieved each response.

2. Progression-free Survival [Duration of study (up to 2 years)]

   Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:

• Squamous cell carcinoma

• Adenocarcinoma (including bronchoalveolar cell)

• Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

• Must meet the following criteria:

• T1-3 with N2 and selected N3*

• T4 with N0, N1, N2 and selected N3*

• M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible.

• Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Nonmeasurable lesions include the following:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural or pericardial effusion

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• Tumor lesions situated in a previously irradiated area

• Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist

• Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months

• Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria

• Pleural effusions meeting the following criteria allowed:

• Effusion is transudate, cytologically negative, and non-bloody

• Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap

• Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted

PATIENT CHARACTERISTICS:

• See Disease Characteristics

• Granulocytes ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Creatinine ≤ 1.5 x upper limit of normal (ULN)

• AST < 2 x ULN

• Bilirubin ≤ ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for NSCLC

• At least 2 weeks since formal exploratory thoracotomy

• No concurrent administration of sucralfate suspension and erlotinib hydrochloride

• No concurrent intensity-modulated radiotherapy

• No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic

• No concurrent palliative radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
2	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California	United States	94546
3	Valley Medical Oncology	Fremont	California	United States	94538
4	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
5	Camino Medical Group - Treatment Center	Mountain View	California	United States	94040
6	El Camino Hospital Cancer Center	Mountain View	California	United States	94040
7	Highland General Hospital	Oakland	California	United States	94602
8	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
9	Bay Area Breast Surgeons, Incorporated	Oakland	California	United States	94609
10	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
11	Larry G Strieff MD Medical Corporation	Oakland	California	United States	94609
12	Tom K Lee, Incorporated	Oakland	California	United States	94609
13	Palo Alto Medical Foundation	Palo Alto	California	United States	94301
14	Doctors Medical Center - San Pablo Campus	San Pablo	California	United States	94806
15	Poudre Valley Radiation Oncology	Fort Collins	Colorado	United States	80528
16	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
17	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
18	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
19	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
20	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
21	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida	United States	33458
22	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
23	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
24	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
25	Menorah Medical Center	Overland Park	Kansas	United States	66209
26	Saint Luke's Hospital - South	Overland Park	Kansas	United States	66213
27	CCOP - Kansas City	Prairie Village	Kansas	United States	66208
28	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
29	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine	United States	04401
30	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
31	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201
32	National Naval Medical Center	Bethesda	Maryland	United States	20889-5600
33	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
34	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
35	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
36	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
37	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
38	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
39	Hurley Medical Center	Flint	Michigan	United States	48503
40	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
41	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
42	Foote Memorial Hospital	Jackson	Michigan	United States	49201
43	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
44	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
45	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
46	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
47	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
48	St. John Macomb Hospital	Warren	Michigan	United States	48093
49	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
50	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
51	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
52	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
53	North Kansas City Hospital	Kansas City	Missouri	United States	64116
54	Parvin Radiation Oncology	Kansas City	Missouri	United States	64116
55	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
56	Research Medical Center	Kansas City	Missouri	United States	64132
57	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
58	Liberty Hospital	Liberty	Missouri	United States	64068
59	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
60	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri	United States	64507
61	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
62	Immanuel Medical Center	Omaha	Nebraska	United States	68122
63	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
64	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
65	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
66	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
67	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire	United States	03301
68	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
69	Lakes Region General Hospital	Laconia	New Hampshire	United States	03246
70	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire	United States	03103
71	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
72	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
73	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
74	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York	United States	12801
75	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
76	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
77	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
78	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
79	Southeastern Regional Medical Center	Lumberton	North Carolina	United States	28359
80	Granville Medical Center	Oxford	North Carolina	United States	27565
81	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina	United States	27607
82	Duke Health Raleigh Hospital	Raleigh	North Carolina	United States	27609
83	Person Memorial Hospital	Roxboro	North Carolina	United States	27573
84	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
85	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
86	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
87	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
88	Barberton Citizens Hospital	Barberton	Ohio	United States	44203
89	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
90	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
91	AnMed Cancer Center	Anderson	South Carolina	United States	29621
92	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
93	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
94	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
95	Danville Regional Medical Center	Danville	Virginia	United States	24541
96	Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	Virginia	United States	24273
97	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
98	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
99	Veterans Affairs Medical Center - Milwaukee	Milwaukee	Wisconsin	United States	53295

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Rogerio Lilenbaum, MD, Cleveland Clinic Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00553462
• Other Study ID Numbers: CALGB-30605; CALGB-30605; CDR0000573832
• First Posted: Nov 4, 2007
• Last Update Posted: Jan 31, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Alliance for Clinical Trials in Oncology: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Paclitaxel; Carboplatin; Erlotinib Hydrochloride; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Recruitment Details	Between March 2008 and October 2011, 78 participants were recruited to this study.
Pre-assignment Detail	Three participants did not receive any protocol treatment and were excluded from all analyses.

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
Period Title: Overall Study
STARTED	75
COMPLETED	61
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
Overall Participants	75
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68
Sex: Female, Male (Count of Participants)
Female	31 41.3%
Male	44 58.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4%
Not Hispanic or Latino	69 92%
Unknown or Not Reported	3 4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	20 26.7%
White	53 70.7%
More than one race	1 1.3%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	75 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival at 12 Months
Description	Percentage of participants who were alive at 12 months.
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
Measure Participants	75
Number (95% Confidence Interval) [percentage of participants]	57 76%

2. Secondary Outcome

Title	Response Rate
Description	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Response rate is reported as the percentage of participants who achieved each response.
Time Frame	Duration of study (up to 2 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
Measure Participants	75
Complete Response (CR)	8 10.7%
Partial Response (PR)	59 78.7%
Stable Disease (SD)	27 36%
Progressive Disease (PD)	7 9.3%

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame	Duration of study (up to 2 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
Measure Participants	75
Median (95% Confidence Interval) [months]	11

Adverse Events

Arm/Group Title	Paclitaxel + Carboplatin + Radiation + Erlotinib
Arm/Group Description	Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
All Cause Mortality
	Paclitaxel + Carboplatin + Radiation + Erlotinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel + Carboplatin + Radiation + Erlotinib
	Affected / at Risk (%)	# Events
Total	19/75 (25.3%)
Blood and lymphatic system disorders
Blood disorder	1/75 (1.3%)	1
Disseminated intravascular coagulation	1/75 (1.3%)	1
Hemoglobin decreased	14/75 (18.7%)	15
Hemolysis	1/75 (1.3%)	2
Cardiac disorders
Atrial fibrillation	3/75 (4%)	4
Atrial flutter	1/75 (1.3%)	1
Cardiac disorder	3/75 (4%)	4
Cardiac pain	2/75 (2.7%)	2
Left ventricular dysfunction	1/75 (1.3%)	1
Myocardial ischemia	2/75 (2.7%)	2
Sinus tachycardia	1/75 (1.3%)	1
Supraventricular extrasystoles	1/75 (1.3%)	1
Ear and labyrinth disorders
Ear pain	1/75 (1.3%)	1
Eye disorders
Vision blurred	1/75 (1.3%)	1
Gastrointestinal disorders
Colonic hemorrhage	1/75 (1.3%)	1
Constipation	7/75 (9.3%)	8
Diarrhea	8/75 (10.7%)	8
Dry mouth	1/75 (1.3%)	1
Dyspepsia	5/75 (6.7%)	5
Dysphagia	6/75 (8%)	6
Ear, nose and throat examination abnormal	2/75 (2.7%)	2
Esophageal mucositis	1/75 (1.3%)	1
Esophagitis	5/75 (6.7%)	5
Ileal hemorrhage	1/75 (1.3%)	1
Lower gastrointestinal hemorrhage	1/75 (1.3%)	1
Nausea	10/75 (13.3%)	13
Vomiting	4/75 (5.3%)	5
General disorders
Chest pain	4/75 (5.3%)	4
Chills	1/75 (1.3%)	2
Edema limbs	2/75 (2.7%)	2
Fatigue	15/75 (20%)	20
Fever	2/75 (2.7%)	2
General symptom	1/75 (1.3%)	1
Pain	1/75 (1.3%)	1
Infections and infestations
Bladder infection	1/75 (1.3%)	1
Bronchitis	1/75 (1.3%)	1
Esophageal infection	1/75 (1.3%)	1
Gingival infection	1/75 (1.3%)	1
Hepatic infection	1/75 (1.3%)	1
Infection	2/75 (2.7%)	3
Opportunistic infection	1/75 (1.3%)	1
Pharyngitis	1/75 (1.3%)	1
Pneumonia	2/75 (2.7%)	3
Sepsis	1/75 (1.3%)	1
Injury, poisoning and procedural complications
Dermatitis radiation	1/75 (1.3%)	1
Radiation recall reaction (dermatologic)	1/75 (1.3%)	1
Investigations
Activated partial thromboplastin time prolonged	2/75 (2.7%)	2
Alanine aminotransferase increased	4/75 (5.3%)	4
Alkaline phosphatase increased	1/75 (1.3%)	1
Aspartate aminotransferase increased	3/75 (4%)	3
Blood bilirubin increased	3/75 (4%)	3
Coagulopathy	1/75 (1.3%)	1
Creatinine increased	7/75 (9.3%)	7
Electrocardiogram QTc interval prolonged	1/75 (1.3%)	1
INR increased	2/75 (2.7%)	2
Laboratory test abnormal	1/75 (1.3%)	1
Leukocyte count decreased	12/75 (16%)	12
Lymphocyte count decreased	8/75 (10.7%)	8
Neutrophil count decreased	6/75 (8%)	6
Platelet count decreased	11/75 (14.7%)	12
Weight loss	7/75 (9.3%)	7
Metabolism and nutrition disorders
Anorexia	11/75 (14.7%)	12
Blood glucose increased	13/75 (17.3%)	14
Blood uric acid increased	1/75 (1.3%)	1
Dehydration	7/75 (9.3%)	8
Serum albumin decreased	7/75 (9.3%)	7
Serum calcium decreased	8/75 (10.7%)	8
Serum glucose decreased	4/75 (5.3%)	4
Serum magnesium decreased	3/75 (4%)	3
Serum magnesium increased	2/75 (2.7%)	2
Serum phosphate decreased	2/75 (2.7%)	2
Serum potassium decreased	7/75 (9.3%)	8
Serum potassium increased	4/75 (5.3%)	4
Serum sodium decreased	3/75 (4%)	4
Serum sodium increased	1/75 (1.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	3/75 (4%)	4
Bone pain	1/75 (1.3%)	1
Chest wall pain	3/75 (4%)	4
Muscle weakness	3/75 (4%)	3
Muscle weakness right-sided	1/75 (1.3%)	1
Pain in extremity	1/75 (1.3%)	1
Nervous system disorders
Depressed level of consciousness	1/75 (1.3%)	1
Dizziness	1/75 (1.3%)	1
Dysgeusia	3/75 (4%)	4
Headache	4/75 (5.3%)	4
Ischemia cerebrovascular	1/75 (1.3%)	1
Mini mental status examination abnormal	1/75 (1.3%)	1
Peripheral motor neuropathy	1/75 (1.3%)	1
Peripheral sensory neuropathy	4/75 (5.3%)	4
Tremor	1/75 (1.3%)	1
Psychiatric disorders
Agitation	2/75 (2.7%)	2
Anxiety	3/75 (4%)	3
Confusion	2/75 (2.7%)	3
Depression	4/75 (5.3%)	4
Personality change	1/75 (1.3%)	1
Psychosis	1/75 (1.3%)	1
Renal and urinary disorders
Proteinuria	1/75 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/75 (1.3%)	1
Bronchospasm	5/75 (6.7%)	6
Cough	8/75 (10.7%)	10
Dyspnea	15/75 (20%)	20
Hiccups	1/75 (1.3%)	1
Hypoxia	4/75 (5.3%)	6
Nasal congestion	1/75 (1.3%)	1
Pleural effusion	1/75 (1.3%)	2
Pneumonitis	2/75 (2.7%)	3
Respiratory disorder	4/75 (5.3%)	5
Voice alteration	1/75 (1.3%)	1
Skin and subcutaneous tissue disorders
Alopecia	2/75 (2.7%)	2
Dry skin	3/75 (4%)	3
Pruritus	1/75 (1.3%)	1
Rash desquamating	9/75 (12%)	10
Sweating	1/75 (1.3%)	1
Vascular disorders
Hot flashes	2/75 (2.7%)	2
Hypertension	2/75 (2.7%)	3
Hypotension	3/75 (4%)	3
Other (Not Including Serious) Adverse Events
	Paclitaxel + Carboplatin + Radiation + Erlotinib
	Affected / at Risk (%)	# Events
Total	71/75 (94.7%)
Blood and lymphatic system disorders
Hemoglobin decreased	48/75 (64%)	98
Hemolysis	2/75 (2.7%)	3
Spleen disorder	1/75 (1.3%)	1
Cardiac disorders
Arrhythmia	1/75 (1.3%)	1
Atrial fibrillation	2/75 (2.7%)	3
Palpitations	1/75 (1.3%)	1
Sinus tachycardia	4/75 (5.3%)	6
Ear and labyrinth disorders
Ear pain	2/75 (2.7%)	3
External ear pain	1/75 (1.3%)	2
Tinnitus	1/75 (1.3%)	3
Endocrine disorders
Cushingoid	1/75 (1.3%)	2
Eye disorders
Cataract	1/75 (1.3%)	3
Conjunctivitis	1/75 (1.3%)	1
Diplopia	1/75 (1.3%)	1
Dry eye syndrome	1/75 (1.3%)	3
Eye disorder	1/75 (1.3%)	1
Eye pain	1/75 (1.3%)	1
Flashing vision	1/75 (1.3%)	3
Vision blurred	1/75 (1.3%)	1
Gastrointestinal disorders
Abdominal pain	9/75 (12%)	12
Constipation	20/75 (26.7%)	28
Diarrhea	27/75 (36%)	40
Dry mouth	3/75 (4%)	5
Dyspepsia	3/75 (4%)	6
Dysphagia	12/75 (16%)	13
Ear, nose and throat examination abnormal	13/75 (17.3%)	13
Esophageal pain	5/75 (6.7%)	5
Esophagitis	16/75 (21.3%)	16
Fecal incontinence	2/75 (2.7%)	3
Flatulence	1/75 (1.3%)	3
Hemorrhoids	3/75 (4%)	3
Mucositis oral	1/75 (1.3%)	1
Nausea	36/75 (48%)	52
Upper gastrointestinal hemorrhage	1/75 (1.3%)	1
Vomiting	22/75 (29.3%)	25
General disorders
Chest pain	3/75 (4%)	5
Chills	3/75 (4%)	3
Edema limbs	7/75 (9.3%)	8
Facial pain	1/75 (1.3%)	1
Fatigue	65/75 (86.7%)	126
Fever	5/75 (6.7%)	5
Gait abnormal	1/75 (1.3%)	1
General symptom	1/75 (1.3%)	1
Injection site reaction	1/75 (1.3%)	1
Pain	5/75 (6.7%)	6
Visceral edema	1/75 (1.3%)	1
Immune system disorders
Hypersensitivity	1/75 (1.3%)	1
Infections and infestations
Bronchitis	2/75 (2.7%)	2
Catheter related infection	1/75 (1.3%)	1
Esophageal infection	1/75 (1.3%)	1
Infection	1/75 (1.3%)	1
Lip infection	1/75 (1.3%)	1
Pneumonia	4/75 (5.3%)	6
Sinusitis	2/75 (2.7%)	2
Skin infection	1/75 (1.3%)	1
Upper respiratory infection	1/75 (1.3%)	1
Urinary tract infection	1/75 (1.3%)	1
Vaginal infection	1/75 (1.3%)	1
Injury, poisoning and procedural complications
Bruising	1/75 (1.3%)	2
Dermatitis radiation	3/75 (4%)	3
Fracture	1/75 (1.3%)	1
Radiation recall reaction (dermatologic)	4/75 (5.3%)	4
Investigations
Activated partial thromboplastin time prolonged	3/75 (4%)	3
Alanine aminotransferase increased	9/75 (12%)	9
Alkaline phosphatase	1/75 (1.3%)	1
Alkaline phosphatase increased	9/75 (12%)	12
Aspartate aminotransferase increased	12/75 (16%)	17
Blood bilirubin increased	5/75 (6.7%)	5
Creatinine increased	8/75 (10.7%)	12
INR increased	1/75 (1.3%)	1
Laboratory test abnormal	1/75 (1.3%)	1
Leukocyte count decreased	28/75 (37.3%)	43
Lymphocyte count decreased	25/75 (33.3%)	34
Neutrophil count decreased	32/75 (42.7%)	48
Platelet count decreased	26/75 (34.7%)	44
Weight gain	1/75 (1.3%)	1
Weight loss	17/75 (22.7%)	21
Metabolism and nutrition disorders
Anorexia	18/75 (24%)	31
Blood bicarbonate decreased	1/75 (1.3%)	1
Blood glucose increased	33/75 (44%)	44
Dehydration	10/75 (13.3%)	12
Serum albumin decreased	18/75 (24%)	29
Serum calcium decreased	6/75 (8%)	10
Serum calcium increased	1/75 (1.3%)	2
Serum glucose decreased	9/75 (12%)	9
Serum magnesium decreased	8/75 (10.7%)	11
Serum phosphate decreased	4/75 (5.3%)	4
Serum potassium decreased	15/75 (20%)	18
Serum potassium increased	5/75 (6.7%)	6
Serum sodium decreased	17/75 (22.7%)	22
Musculoskeletal and connective tissue disorders
Arthralgia	5/75 (6.7%)	11
Arthritis	2/75 (2.7%)	4
Back pain	8/75 (10.7%)	15
Bone pain	1/75 (1.3%)	1
Chest wall pain	7/75 (9.3%)	9
Muscle weakness	6/75 (8%)	10
Muscle weakness upper limb	1/75 (1.3%)	1
Musculoskeletal disorder	1/75 (1.3%)	1
Myalgia	3/75 (4%)	6
Pain in extremity	6/75 (8%)	8
Nervous system disorders
Ataxia	1/75 (1.3%)	1
Dizziness	9/75 (12%)	18
Dysgeusia	8/75 (10.7%)	11
Extrapyramidal disorder	1/75 (1.3%)	2
Headache	7/75 (9.3%)	14
Peripheral motor neuropathy	2/75 (2.7%)	5
Peripheral sensory neuropathy	20/75 (26.7%)	34
Seizure	1/75 (1.3%)	1
Tremor	3/75 (4%)	5
Psychiatric disorders
Anxiety	6/75 (8%)	11
Confusion	2/75 (2.7%)	2
Depression	7/75 (9.3%)	10
Euphoria	1/75 (1.3%)	1
Insomnia	12/75 (16%)	17
Renal and urinary disorders
Bladder pain	1/75 (1.3%)	1
Kidney pain	1/75 (1.3%)	1
Urethral pain	1/75 (1.3%)	1
Urinary frequency	2/75 (2.7%)	2
Urinary incontinence	1/75 (1.3%)	3
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/75 (1.3%)	1
Atelectasis	1/75 (1.3%)	1
Bronchospasm	6/75 (8%)	10
Cough	26/75 (34.7%)	44
Dyspnea	48/75 (64%)	88
Epistaxis	6/75 (8%)	7
Hiccups	3/75 (4%)	4
Hypoxia	1/75 (1.3%)	1
Nasal congestion	1/75 (1.3%)	1
Pharyngeal examination abnormal	1/75 (1.3%)	1
Pharyngolaryngeal pain	2/75 (2.7%)	2
Pleural effusion	1/75 (1.3%)	1
Pleuritic pain	1/75 (1.3%)	1
Pulmonary hemorrhage	1/75 (1.3%)	2
Respiratory disorder	5/75 (6.7%)	6
Respiratory tract hemorrhage	2/75 (2.7%)	2
Voice alteration	4/75 (5.3%)	5
Skin and subcutaneous tissue disorders
Alopecia	23/75 (30.7%)	36
Dry skin	4/75 (5.3%)	6
Hand-and-foot syndrome	1/75 (1.3%)	1
Nail disorder	1/75 (1.3%)	1
Pruritus	9/75 (12%)	12
Rash acneiform	5/75 (6.7%)	5
Rash desquamating	34/75 (45.3%)	38
Scalp pain	1/75 (1.3%)	1
Skin disorder	4/75 (5.3%)	6
Skin hyperpigmentation	1/75 (1.3%)	1
Urticaria	1/75 (1.3%)	2
Vascular disorders
Flushing	2/75 (2.7%)	4
Hemorrhage	1/75 (1.3%)	1
Hot flashes	3/75 (4%)	5
Hypertension	3/75 (4%)	5
Hypotension	3/75 (4%)	4
Vascular disorder	1/75 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.