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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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)


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.

Inclusion Criteria


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

- Unspecified

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Selection of one of two treatment regimens (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further study in a phase III trial, based on median progression-free survival for ≥ 3 months

Outcome Time Frame:

From date of registration to 3 years or death, whichever comes first

Safety Issue:

No

Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000593575

NCT ID:

NCT00661193

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Harrington Cancer CenterAmarillo, Texas  79106
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Peninsula Medical CenterBurlingame, California  94010
Kaiser Permanente - FremontFremont, California  94538
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
California Pacific Medical Center - California CampusSan Francisco, California  94118
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Sutter Solano Medical CenterVallejo, California  94589
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Highland General HospitalOakland, California  94602
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Kaiser Permanente - Deer ValleyAntioch, California  94531
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Kaiser Permanente - Moanalua Medical Center and ClinicHonolulu, Hawaii  96819
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
El Camino Hospital Cancer CenterMountain View, California  94040
Tahoe Forest Cancer CenterTruckee, California  96161
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Saint Luke's Mountain States Tumor Institute - FruitlandFruitland, Idaho  83619
Mountain States Tumor Institute - MeridianMeridian, Idaho  83642
Mountain States Tumor Institute at St. Luke'sTwin Falls, Idaho  83301
St. Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Kaiser Permanente Medical Center - VacavilleVacaville, California  95688
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Epic Care - OaklandOakland, California  94612
Veterans Affairs Medical Center - Topeka (O'Neil)Topeka, Kansas  66622