S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00436332
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 84
• Locations: 148
• Arm: 1
• Duration (Months): 145.6
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Biological: bevacizumab; Drug: erlotinib hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.

Secondary

• Determine the progression-free survival of patients treated with this regimen.

• Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen.

• Assess the frequency and severity of toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Jul 20, 2019
• Actual Study Completion Date: Aug 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erlotinib and Bevacizumab	Biological: bevacizumab; Drug: erlotinib hydrochloride

Outcome Measures

Primary Outcome Measures

1. Overall Survival [From date of registration to maximum of 3 years]

Secondary Outcome Measures

1. Progression-free Survival [From date of registration to maximum of 3 years]

2. Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease [From date of registration to maximum of 3 years]

   Images for response assessed by the central computer-assisted image-analysis system were never collected.

3. Frequency and Severity of Toxicities [From date of registration to maximum of 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:

• Incompletely resected or unresectable disease

• No component of squamous cell carcinoma

• Disease staged as 1 of the following:

• Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor], any N, M0)

• Stage IV disease (any T, any N, M1 [distant metastases present])

• Recurrent disease in a separate lobe after prior resection within the past 5 years; multifocal lesions in > 1 lobe; or any disease that is recurrent after surgery or radiotherapy is considered stage IV disease

• Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis

• Measurable or nonmeasurable disease by chest CT scan

• Pleural effusions, ascites, and laboratory parameters are not acceptable as only evidence of disease

• Disease must be present outside field of prior radiotherapy OR a new lesion must be inside port

• Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Total bilirubin normal

• AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)

• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

• Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine collection

• Willing to provide prior smoking history

• No hemoptysis ≥ ½ teaspoon within the past 28 days

• No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the past 6 months or > grade 1 within the past 28 days

• No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding

• No uncontrolled hypertension

• No serious nonhealing wound, ulcer, or bone fracture

• No other prior malignancy except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer

• In situ cervical cancer

• Adequately treated stage I or II cancer that is currently in complete remission

• Any other cancer from which the patient has been disease free for 5 years

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)

• At least 28 days since prior surgery (thoracic or other major surgeries)

• More than 7 days since prior fine-needle aspiration or core biopsy

• At least 28 days since prior systemic chemotherapy or biologic therapy

• No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab

• No other prior anti-epidermal growth factor receptor or anti-vascular endothelial growth factor therapies

• Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation

• No other concurrent anticancer therapy, including surgery, chemotherapy, hormone therapy, biologic therapy, or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
2	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
3	Peninsula Medical Center	Burlingame	California	United States	94010
4	Kaiser Permanente - Fremont	Fremont	California	United States	94538
5	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
6	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
7	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
8	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California	United States	94588
9	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
10	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
11	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
12	University of California Davis Cancer Center	Sacramento	California	United States	95817
13	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
14	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
15	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
16	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
17	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
18	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
19	Sutter Health - Western Division Cancer Research Group	San Rafael	California	United States	94903
20	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
21	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
22	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
23	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
24	Tahoe Forest Cancer Center	Truckee	California	United States	96161
25	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
26	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
27	Sutter Solano Medical Center	Vallejo	California	United States	94589
28	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
29	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
30	Piedmont Hospital	Atlanta	Georgia	United States	30309
31	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
32	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
33	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
34	WellStar Cobb Hospital	Austell	Georgia	United States	30106
35	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
36	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
37	Piedmont Fayette Hospital	Fayetteville	Georgia	United States	30214
38	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
39	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
40	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
41	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
42	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia	United States	30165
43	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
44	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
45	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
46	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
47	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
48	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
49	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
50	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
51	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
52	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
53	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
54	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
55	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
56	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
57	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
58	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
59	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
60	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
61	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
62	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
63	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
64	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
65	CCOP - Wichita	Wichita	Kansas	United States	67214
66	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
67	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
68	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
69	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
70	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
71	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
72	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
73	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
74	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
75	Hurley Medical Center	Flint	Michigan	United States	48503
76	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
77	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
78	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
79	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
80	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
81	Foote Memorial Hospital	Jackson	Michigan	United States	49201
82	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
83	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
84	Mercy General Health Partners	Muskegon	Michigan	United States	49443
85	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
86	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
87	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
88	Munson Medical Center	Traverse City	Michigan	United States	49684
89	St. John Macomb Hospital	Warren	Michigan	United States	48093
90	Metro Health Hospital	Wyoming	Michigan	United States	49519
91	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
92	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
93	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
94	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
95	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
96	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
97	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
98	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
99	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
100	Northern Montana Hospital	Havre	Montana	United States	59501
101	St. Peter's Hospital	Helena	Montana	United States	59601
102	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
103	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
104	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
105	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
106	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
107	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
108	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
109	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
110	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
111	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
112	CCOP - Columbus	Columbus	Ohio	United States	43215
113	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
114	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
115	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
116	Grady Memorial Hospital	Delaware	Ohio	United States	43015
117	Fairfield Medical Center	Lancaster	Ohio	United States	43130
118	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
119	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
120	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
121	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
122	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
123	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
124	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
125	American Fork Hospital	American Fork	Utah	United States	84003
126	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
127	Logan Regional Hospital	Logan	Utah	United States	84321
128	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
129	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
130	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
131	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
132	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
133	LDS Hospital	Salt Lake City	Utah	United States	84143
134	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
135	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
136	Columbia Basin Hematology	Kennewick	Washington	United States	99336
137	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98274
138	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
139	Harborview Medical Center	Seattle	Washington	United States	98104
140	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
141	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
142	Group Health Central Hospital	Seattle	Washington	United States	98112
143	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
144	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
145	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
146	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
147	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
148	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Howard L. West, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 2, 2011

More Information

Publications

• West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00436332
• Other Study ID Numbers: CDR0000529756; S0635; U10CA032102
• First Posted: Feb 19, 2007
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Southwest Oncology Group: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; bronchoalveolar cell lung cancer; adenocarcinoma of the lung
• Additional relevant MeSH terms: Lung Neoplasms; Adenocarcinoma, Bronchiolo-Alveolar; Bevacizumab; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Period Title: Overall Study
STARTED	84
Eligible	82
Eligible and Began Protocol Therapy	79
COMPLETED	1
NOT COMPLETED	83

Baseline Characteristics

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Overall Participants	79
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	69.2
Sex: Female, Male (Count of Participants)
Female	41 51.9%
Male	38 48.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.3%
Not Hispanic or Latino	73 92.4%
Unknown or Not Reported	5 6.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 7.6%
White	72 91.1%
More than one race	0 0%
Unknown or Not Reported	1 1.3%
Histology (Count of Participants)
Adenocarcinoma with Bronchioloalveolar Carcinoma	56 70.9%
Bronchioloalveolar Carcinoma	23 29.1%
Performance Status (Count of Participants)
0	37 46.8%
1	39 49.4%
2	3 3.8%
Smoking History (Count of Participants)
Current	11 13.9%
Former	61 77.2%
Never	7 8.9%
Stage (Count of Participants)
IIIB	3 3.8%
IV	76 96.2%
Weight Loss Last 6 Months (Count of Participants)
<5%	57 72.2%
5-<10%	8 10.1%
10-20%	10 12.7%
Unknown	4 5.1%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Time Frame	From date of registration to maximum of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Measure Participants	79
Median (95% Confidence Interval) [months]	21

2. Secondary Outcome

Title	Progression-free Survival
Time Frame	From date of registration to maximum of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Measure Participants	79
Median (95% Confidence Interval) [months]	5

3. Secondary Outcome

Title	Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease
Description	Images for response assessed by the central computer-assisted image-analysis system were never collected.
Time Frame	From date of registration to maximum of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Measure Participants	79
Confirmed Complete Response	2 2.5%
Confirmed Partial Response	5 6.3%
Unconfirmed Partial Response	8 10.1%
Stable/No Response	33 41.8%
Progression	11 13.9%
Symptomatic Deterioration	1 1.3%
Early Death	1 1.3%
Assessment Inadequate	2 2.5%
Non Measurable Baseline Disease Status	16 20.3%

4. Secondary Outcome

Title	Frequency and Severity of Toxicities
Time Frame	From date of registration to maximum of 3 years

Outcome Measure Data

Analysis Population Description

Number of Subjects With Greater Than Grade 2 Toxicity

Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Measure Participants	79
AST, SGOT	1 1.3%
Albumin, serum-low (hypoalbuminemia)	1 1.3%
Anorexia	2 2.5%
Ataxia (incoordination)	1 1.3%
CNS cerebrovascular ischemia	3 3.8%
Carbon monoxide diffusion capacity (DL(co))	1 1.3%
Creatinine	1 1.3%
Dehydration	3 3.8%
Diarrhea	12 15.2%
Dry skin	1 1.3%
Dyspnea (shortness of breath)	2 2.5%
Extremity-lower (gait/walking)	1 1.3%
Fatigue (asthenia, lethargy, malaise)	9 11.4%
Hypertension	6 7.6%
Hypoxia	2 2.5%
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	2 2.5%
Left ventricular diastolic dysfunction	1 1.3%
Left ventricular systolic dysfunction	1 1.3%
Mucositis/stomatitis (clinical exam) - Oral cavity	1 1.3%
Mucositis/stomatitis (functional/symp) - Oral cav	1 1.3%
Muscle weakness, not d/t neuropathy - body/general	2 2.5%
Nail changes	1 1.3%
Nausea	2 2.5%
Ocular/Visual-Other (Specify)	1 1.3%
Pain - Chest wall	1 1.3%
Pain - Extremity-limb	1 1.3%
Pain - Head/headache	2 2.5%
Potassium, serum-high (hyperkalemia)	1 1.3%
Potassium, serum-low (hypokalemia)	3 3.8%
Proteinuria	3 3.8%
Pruritus/itching	2 2.5%
Pulmonary/Upper Respiratory-Other (Specify)	1 1.3%
Rash/desquamation	5 6.3%
Rash: acne/acneiform	9 11.4%
Rash: hand-foot skin reaction	4 5.1%
Renal failure	1 1.3%
Renal/Genitourinary-Other (Specify)	1 1.3%
Retinal detachment	1 1.3%
Sodium, serum-low (hyponatremia)	2 2.5%
Speech impairment (e.g., dysphasia or aphasia)	1 1.3%
Syncope (fainting)	1 1.3%
Ulcer, GI - Duodenum	1 1.3%
Ulcer, GI - Stomach	1 1.3%
Ulceration	1 1.3%
Vomiting	1 1.3%
Weight loss	3 3.8%
Wound complication, non-infectious	1 1.3%

Adverse Events

Time Frame	From date of registration to maximum of 3 years.
Adverse Event Reporting Description	Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Arm/Group Title	Erlotinib and Bevacizumab
Arm/Group Description	Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
All Cause Mortality
	Erlotinib and Bevacizumab
	Affected / at Risk (%)	# Events
Total	56/79 (70.9%)
Serious Adverse Events
	Erlotinib and Bevacizumab
	Affected / at Risk (%)	# Events
Total	6/79 (7.6%)
Cardiac disorders
Left ventricular diastolic dysfunction	1/79 (1.3%)
Eye disorders
Retinal detachment	1/79 (1.3%)
Gastrointestinal disorders
Ulcer, GI - Stomach	1/79 (1.3%)
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1/79 (1.3%)
Investigations
Carbon monoxide diffusion capacity (DL(co))	1/79 (1.3%)
Creatinine	1/79 (1.3%)
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)	1/79 (1.3%)
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))	1/79 (1.3%)
Dyspnea (shortness of breath)	1/79 (1.3%)
Hypoxia	1/79 (1.3%)
Skin and subcutaneous tissue disorders
Ulceration	1/79 (1.3%)
Other (Not Including Serious) Adverse Events
	Erlotinib and Bevacizumab
	Affected / at Risk (%)	# Events
Total	77/79 (97.5%)
Blood and lymphatic system disorders
Hemoglobin	15/79 (19%)
Eye disorders
Dry eye syndrome	6/79 (7.6%)
Gastrointestinal disorders
Constipation	13/79 (16.5%)
Diarrhea	56/79 (70.9%)
Heartburn/dyspepsia	11/79 (13.9%)
Mucositis/stomatitis (clinical exam) - Oral cavity	13/79 (16.5%)
Mucositis/stomatitis (functional/symp) - Oral cav	12/79 (15.2%)
Nausea	31/79 (39.2%)
Vomiting	12/79 (15.2%)
General disorders
Edema: limb	4/79 (5.1%)
Fatigue (asthenia, lethargy, malaise)	55/79 (69.6%)
Rigors/chills	4/79 (5.1%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	11/79 (13.9%)
AST, SGOT	18/79 (22.8%)
Alkaline phosphatase	8/79 (10.1%)
Bilirubin (hyperbilirubinemia)	18/79 (22.8%)
Creatinine	14/79 (17.7%)
Leukocytes (total WBC)	4/79 (5.1%)
Metabolic/Laboratory-Other	6/79 (7.6%)
Weight loss	29/79 (36.7%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	16/79 (20.3%)
Anorexia	28/79 (35.4%)
Calcium, serum-low (hypocalcemia)	5/79 (6.3%)
Dehydration	8/79 (10.1%)
Glucose, serum-high (hyperglycemia)	7/79 (8.9%)
Potassium, serum-low (hypokalemia)	10/79 (12.7%)
Sodium, serum-low (hyponatremia)	13/79 (16.5%)
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general	7/79 (8.9%)
Pain - Extremity-limb	5/79 (6.3%)
Pain - Joint	8/79 (10.1%)
Pain - Muscle	5/79 (6.3%)
Nervous system disorders
Dizziness	7/79 (8.9%)
Neuropathy: sensory	7/79 (8.9%)
Pain - Head/headache	9/79 (11.4%)
Taste alteration (dysgeusia)	15/79 (19%)
Psychiatric disorders
Insomnia	4/79 (5.1%)
Renal and urinary disorders
Proteinuria	17/79 (21.5%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	8/79 (10.1%)
Cough	12/79 (15.2%)
Dyspnea (shortness of breath)	14/79 (17.7%)
Hemorrhage, pulmonary/upper respiratory - Nose	26/79 (32.9%)
Pulmonary/Upper Respiratory-Other	5/79 (6.3%)
Voice changes/dysarthria	11/79 (13.9%)
Skin and subcutaneous tissue disorders
Dry skin	18/79 (22.8%)
Hair loss/Alopecia (scalp or body)	23/79 (29.1%)
Nail changes	5/79 (6.3%)
Pruritus/itching	18/79 (22.8%)
Rash/desquamation	28/79 (35.4%)
Rash: acne/acneiform	58/79 (73.4%)
Rash: hand-foot skin reaction	11/79 (13.9%)
Vascular disorders
Hypertension	21/79 (26.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.