S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:December 2008
End Date:December 2016

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A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2)

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. 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 or by
stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may
kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone
or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV
non-small cell lung cancer.

OBJECTIVES:

Primary

- To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel)
for further testing against standard treatment, based on median progression-free
survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer
with a Zubrod performance status of 2.

Secondary

- To assess the feasibility of selecting patients for a trial based on central EGFR
testing of serum in a cooperative group setting.

- To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and
partial response), in a subset of patients with measurable disease.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats
every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses,
patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib
hydrochloride repeat 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 2 years.

DISEASE CHARACTERISTICS:

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

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Newly diagnosed primary disease OR recurrent disease after prior surgery and/or
radiotherapy, meeting 1 of the following staging criteria:

- Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only],
any N, M0)

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

- Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear
scan

- The CT scan from a combined PET/CT scan may only be used to document
nonmeasurable disease

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

- Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics
positive") prior to study registration

- No untreated brain metastases

- Patients with treated brain metastases are allowed provided metastases have
remained controlled for at least two weeks following treatment, AND patient has
no residual neurological dysfunction off corticosteroids

- Patients with neurologic abnormalities on physical examination or symptoms must
have a negative pretreatment CT or MRI scan of the brain 28 days prior to
registration

PATIENT CHARACTERISTICS:

- Zubrod performance status 2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 1,000/mm³

- Serum bilirubin normal

- SGOT or SGPT normal

- Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min

- Willing to provide prior smoking history as requested on the prestudy form

- No gastrointestinal (GI) tract disease resulting in an inability to take enteral
medication

- No malabsorption syndrome or requirement for IV alimentation

- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

- No significant history of cardiac disease, including any of the following:

- Uncontrolled high blood pressure

- Unstable angina

- Congestive heart failure

- Myocardial infarction within the past 6 months

- Cardiac ventricular arrhythmia requiring medication

- No other prior malignancy except 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, or 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

- At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery)
and recovered

- At least 1 year since prior adjuvant chemotherapy

- No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced
NSCLC

- No prior EGFR inhibitors

- No prior surgical procedures affecting absorption

- No concurrent major surgery
We found this trial at
124
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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2720 Clare Avenue
Bremerton, Washington 98310
360-479-6154
Olympic Hematology and Oncology We provide outpatient cancer services in a refined environment designed specifically...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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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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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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1415 E. Kincaid
Mount Vernon, Washington 98273
360-424-4111
Skagit Valley Hospital Cancer Care Center We know that treatment takes its toll physically, emotionally...
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
(360) 598-7500
Harrison Poulsbo Hematology and Onocology Harrison Poulsbo's new Hematology & Oncology center provides outpatient cancer...
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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747 Broadway
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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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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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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Amarillo, Texas 79106
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1211 24th Street
Anacortes, Washington 98221
(360) 299-1300
Island Hospital Cancer Care Center at Island Hospital sland Hospital is the center for health...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Antioch, California 94531
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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3301 Squalicum Parkway
Bellingham, Washington 98225
(360) 788-8222
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
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2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
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1101 N 27th St # 201
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(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
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Billings, Montana 59101
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Billings, Montana 59107
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1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
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931 Highland Blvd
Bozeman, Montana 59715
(406) 585-5070
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16233 Sylvester Rd SW #110
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(206) 439-5577
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Burlingame, California 94010
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Burlington, Massachusetts 01805
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6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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39400 Paseo Padre Parkway
Fremont, California 94538
(510) 248-3000
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Goldsboro, North Carolina 27534
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Great Bend, Kansas 67530
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1101 26th Street South
Great Falls, Montana 59405
406.455.5000
Sletten Cancer Institute at Benefis Healthcare Benefis Hospitals has 516 beds at its two campuses...
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Great Falls, Montana 59405
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114 Woodland St, Hartford
Hartford, Connecticut 06105
(860) 714-4000
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center While better...
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2220 Canterbury Drive
Hays, Kansas 67601
785.623.5000
Hays Medical Center Hays Medical Center is a private, not-for-profit hospital formed by the 1991...
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Hayward, California 94545
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2475 Broadway St
Helena, Montana 59601
(406) 442-2480
St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
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Hutchinson, Kansas 65702
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Issaquah, Washington 98029
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205 North East Avenue
Jackson, Michigan 49201
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75 Claremont St Ste E
Kalispell, Montana 59901
(406) 752-7600
Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
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310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Kansas City, Kansas 66112
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
913.588.1227#sthash.z9pLd
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center The Kansas Masons...
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Kansas City, Missouri 64108
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Kansas City, Missouri 64128
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Kansas City, Missouri 64131
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8700 N. Green Hills Road
Kansas City, Missouri 64154
816.746.4570
Kansas City Cancer Centers - North Through world-class research and patient care, The University of...
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Kennewick, Washington 99336
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-2890
Sparrow Regional Cancer Center Sparrow has grown to become the region's largest health system, and...
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Lee's Summit, Missouri 64064
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4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
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36475 Five Mile
Livonia, Michigan 48154
734-655-4800
St. Mary Mercy Hospital St. Mary Mercy Hospital, located at 36475 Five Mile Road at...
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2500 Alhambra Ave
Martinez, California 94553
(925) 370-5000
Contra Costa Regional Medical Center Contra Costa Health Services is the largest department of County...
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500 W Broadway St
Missoula, Montana 59802
(406) 543-7271
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center St. Patrick Hospital is...
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2490 Hospital Dr
Mountain View, California 94040
(650) 988-8338
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Oakland, California 94611
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400 30th Street, Suite 301
Oakland, California 94609
(510) 465-8016
CCOP - Bay Area Tumor Institute he Bay Area Tumor Institute Community Clinical Oncology Program...
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350 Hawthorne Ave
Oakland, California 94609
(510) 655-4000
Alta Bates Summit Medical Center - Summit Campus Alta Bates Summit Medical Center offers comprehensive...
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1411 E 31st St
Oakland, California 94602
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Highland General Hospital Highland Hospital is the largest campus of Alameda Health System. With 236...
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2633 Telegraph Ave
Oakland, California 94612
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12200W. 110th Street
Overland Park, Kansas 66210
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Kansas City Cancer Centers - Southwest Through world-class research and patient care, The University of...
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2809 Denny Ave
Pascagoula, Mississippi 39581
228-809-5251
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Pittsburg, Kansas 66762
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44405 Woodward Ave
Pontiac, Michigan 48341
(248) 858-3000
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2601 Electric Ave
Port Huron, Michigan 48060
(810) 985-1500
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Redwood City, California 94063
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Richmond, California 94801
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Sacramento, California 95825
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800 S Washington Ave
Saginaw, Michigan 48601
(989) 907-8115
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
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3700 California Street
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2000 Vale Road
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San Rafael, California 94903
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Santa Rosa, California 95403
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