S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:July 15, 2009
End Date:August 31, 2019

Use our guide to learn which trials are right for you!

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

This randomized phase III trial studies carboplatin and paclitaxel to compare how well they
work with or without bevacizumab and/or cetuximab in treating patients with stage IV or
non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs
used in chemotherapy, such as carboplatin and paclitaxel, 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. Bevacizumab may prevent the growth of new blood vessels that
tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and
interfering with a protein on the surface of the tumor cell that is needed for tumor growth.
It is not yet known whether giving carboplatin and paclitaxel are more effective with or
without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in the entire study population. II. To compare
progression-free survival (PFS) by institutional review of epidermal growth factor receptor
(EGFR) fluorescent in situ hybridization (FISH)-positive patients.

SECONDARY OBJECTIVES:

I. To compare OS and PFS by centralized review in EGFR FISH-positive patients. II. To compare
PFS by centralized image review and by institutional review in the entire study population.

III. To compare the response rate (confirmed plus unconfirmed, complete and partial
responses) in a subset of patients with measurable disease in EGFR FISH-positive patient and
the entire study population.

IV. To assess the toxicities of these treatment regimens. V. To prospectively test EGFR FISH
as a predictive marker for the selection of patients for cetuximab plus chemotherapy.

III. To evaluate the role of V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS)
mutations in terms of cetuximab efficacy.

IV. To compare the results of EGFR FISH with KRAS mutations, EGFR mutations, EGFR
immunohistochemistry (IHC), and other purported EGFR-related biomarkers.

TERTIARY OBJECTIVES:

I. To compare PFS in patients with advanced non-small cell lung cancer (NSCLC) with an IHC
score > 200 treated with carboplatin, paclitaxel, and bevacizumab (if appropriate) with or
without cetuximab.

II. To compare OS in patients with advanced NSCLC with an IHC score > 200 treated with
carboplatin, paclitaxel, and bevacizumab (if appropriate) with or without cetuximab.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30
minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every
21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of 6 courses, patients receiving bevacizumab may continue to receive
bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I.
Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or
without bevacizumab (as above) in the absence of disease progression or unacceptable
toxicity.

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

Inclusion Criteria:

- Patients must have histologically or cytologically proven primary non-small cell lung
cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must
be stage IV; disease may be either newly diagnosed or recurrent after previous surgery
and/or irradiation; patients with additional lesions in an ipsilateral non-primary
lobe without M1a or M1b disease will not be considered to have stage IV disease and
are not eligible

- Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan
of the brain to evaluate for central nervous system (CNS) disease within 42 days prior
to registration; patient must not have brain metastases unless: (1) metastases have
been treated and have remained controlled for at least two weeks following treatment,
AND (2) patient has no residual neurological dysfunction off corticosteroids for at
least 1 day

- Patients may have measurable or non-measurable disease documented by CT or MRI; the CT
from a combined positron emission tomography (PET)/CT may be used to document only
non-measurable disease unless it is of diagnostic quality; measurable disease must be
assessed within 28 days prior to registration; pleural effusions, ascites and
laboratory parameters are not acceptable as the only evidence of disease;
non-measurable disease must be assessed within 42 days prior to registration; all
disease must be assessed and documented on the Baseline Tumor Assessment Form

- Patients must have tumor tissue available for submission that is sufficient for EGFR
FISH testing and must agree to submission of these specimens; patients must also agree
to submission of specimens for other translational medicine studies; patient must be
offered participation in banking for future research

- Patients must not have received prior chemotherapy for any stage non-small cell lung
cancer; patients must not have received prior platinum-based chemotherapy for any
purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other
investigational agents that target the EGFR pathway; patients must not have received
for any purpose prior bevacizumab or other vascular endothelial growth factor
(VEGF)-related agents; patients must not have received for any purpose prior
chimerized or murine monoclonal antibody therapy or have documented presence of human
anti-mouse antibodies (HAMA)

- Prior radiation is permitted; however, patients must have recovered from all
associated toxicities at time of registration; in order to qualify as measurable,
measurable disease must be outside the previous radiation field or must have
progressed

- Time from surgical or biopsy procedures is dependent on whether it is planned for the
patient to receive bevacizumab

- For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least
28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted
thoracoscopic surgery [VATS] resection of lung cancer, open pleural biopsy or
another major surgical procedure such as abdominal surgery) or significant
traumatic injury; patients must have recovered from all associated toxicities at
the time of registration; there must be no anticipation of need for major
surgical procedures during protocol treatment; patients must not have had a core
biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial
window within 14 days prior to registration; patients must not have had a
percutaneous fine needle aspiration (FNA), thoracentesis or central venous access
device implanted within 7 days prior to registration; for other surgical
procedures not listed here, please contact the study coordinators

- For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at
least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS
resection of lung cancer, open pleural biopsy or another major surgical procedure
such as abdominal surgery) or significant traumatic injury; patients must have
recovered from all associated toxicities at the time of registration; there must
be no anticipation of need for major surgical procedures during protocol
treatment; patients must not have had a core biopsy, mediastinoscopy,
pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior
to registration; patients must not have had a percutaneous fine needle aspiration
(FNA), or thoracentesis within 1 day prior to registration; patients may have had
a central venous access device placed at any time prior to registration; for
other surgical procedures not listed here, please contact the study coordinators

- Absolute neutrophil count (ANC) >= 1,500/mcl

- Platelet count >= 100,000/mcl

- Hemoglobin >= 9 g/dL

- Serum creatinine =< institutional upper limit of normal (IULN) AND calculated or
measured creatinine clearance >= 50 cc/min using the following Cockroft-Gault formula

- For patients who will be receiving bevacizumab, urine protein must be screened by
urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour
urine protein must be obtained and the level must be < 1,000 mg for patient
enrollment; the urine protein used to calculate the UPC ratio must be obtained within
14 days prior to registration; UPC or 24-hour protein is not required for patients who
will not receive bevacizumab Note: UPC ratio of spot urine is an estimation of the
24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour
urine protein of 1 gm

- Serum bilirubin =< 2 times IULN (for patients with liver metastases, bilirubin must be
=< 5 X IULN)

- Serum glutamic oxaloacetic transaminase (SGOT) OR serum glutamate pyruvate
transaminase (SGPT) =< 2 times IULN (for patients with liver metastases, either SGOT
or SGPT must be =< 5 X IULN)

- Zubrod performance status 0-1

- Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer
Institute [NCI] Common Terminology Criteria version 3.0)

- Patients must not have documented evidence of acute hepatitis or have an active or
uncontrolled infection

- Patients must not have the following: history (within past 6 months) of
cerebrovascular accident (CVA), myocardial infarction or unstable angina; or at the
time of registration, uncontrolled hypertension, New York Heart Association grade 2 or
greater congestive heart failure, serious cardiac arrhythmia requiring medication, or
clinically significant peripheral vascular disease

- Patients must have no known hypersensitivity to Chinese hamster ovary cell products or
other recombinant human antibodies (examples include trastuzumab [Herceptin] and
epoetin alpha)

- Patients must be willing to provide prior smoking history

- No other prior malignancy is allowed 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 from which the patient is currently in
complete remission

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

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- Patients or their legally authorized representative must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
We found this trial at
800
sites
361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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1147 NW 64th Ter
Gainesville, Florida 32605
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jupiter, Florida 33458
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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1100 Fairview Avenue North
Seattle, Washington 98109
206-667-4584
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium The Fred Hutchinson/University of Washington Cancer...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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Adrian, Michigan 49221
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818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Alamosa, Colorado 81101
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Albany, Georgia 31701
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Alton, Illinois 62002
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Ames, Iowa 50010
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1111 Duff Ave
Ames, Iowa 50010
(866) 972-5477
McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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Anacortes, Washington 98221
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Anderson, South Carolina 29621
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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Antigo, Wisconsin 54409
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Appleton, Wisconsin 54915
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, Georgia 30342
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Auburn, Washington 98002
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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Austell, Georgia 30106
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Austin, Texas 78759
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Austin, Texas 78705
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, Maryland 21237
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Baton Rouge, Louisiana 70806
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Baton Rouge, Louisiana 70806
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70809
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bay City, Michigan 48708
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205 Palmer Ave.
Bellefontaine, Ohio 43311
937.592.4015
Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
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Bellevue, Washington 98004
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Bellingham, Washington 98225
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bennington, Vermont 05201
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Bettendorf, Iowa 52722
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Beverly, Massachusetts 01915
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Big Rapids, Michigan 49307
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90 Poly Drive, Suite 2
Billings, Montana 59101
(406) 237-5460
Montana Cancer Consortium CCOP The Montana Cancer Consortium is a nonprofit organization whose mission is...
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Billings, Montana 59101
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, Illinois 61701
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Boca Raton, Florida 33486
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1501 North Oakland Drive
Bolivar, Missouri 65613
417-326-7200
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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Boone, Iowa 50036
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
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960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Branson, Missouri 65616
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Brighton, Massachusetts 02135
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Brooklyn, New York 11235
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