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A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781; IND# 63,383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Bronchoalveolar Cell Lung Cancer, Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781; IND# 63,383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers


PRIMARY OBJECTIVES:

I. Determine the progression-free survival of patients with chemotherapy-naïve select stage
IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without
carboplatin and paclitaxel.

SECONDARY OBJECTIVES:

I. Determine the radiographic response rate in patients treated with these regimens.

II. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras
mutations with the response rate and time to progression in patients treated with these
regimens.

III. Determine the median and overall survival of patients treated with these regimens.

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

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

ARM II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3
hours and carboplatin IV over 15-30 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 of treatment, patients may continue to receive erlotinib alone as
above.

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


Inclusion Criteria:



- Renal: Creatinine =< 1.5 mg/dL

- Histologically confirmed primary non-small cell lung cancer (NSCLC)

- Adenocarcinoma histology, including any of the following histologic variants: pure or
mixed bronchoalveolar cell carcinoma, adenosquamous cell carcinoma

- No NSCLC not otherwise specified

- Pathology block or unstained slides from initial or subsequent diagnosis available

- At least a core biopsy required

- Fine needle aspirate alone is not sufficient

- Meets 1 of the following stage criteria: s

- elect stage IIIB disease with cytologically documented malignant pleural or

- pericardial effusion or stage IV disease

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
conventional techniques OR >= 10 mm by spiral CT scan

- The following are considered non-measurable disease:

- bone lesions,

- leptomeningeal disease;

- ascites;

- pleural or pericardial effusion;

- lymphangitis cutis/pulmonis;

- abdominal masses not confirmed and followed by imaging techniques;

- cystic lesions

- Meets 1 of the following criteria for smoking history:

- non-smoker,

- defined as a person who smoked =< 100 cigarettes in their lifetime;

- former light smoker,

- defined as a person who smoked =< 10 pack years AND

- quit smoking >= 1 year ago

- No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically
unstable, symptomatic, and/or requires corticosteroids)

- ECOG 0-1

- Hematopoietic:

- Granulocyte count >= 1,500/mm^3;

- Platelet count >= 100,000/mm^3;

- Hemoglobin >= 9.0 g/dL

- Hepatic:

- AST =< 2.5 times upper limit of normal (ULN);

- Total bilirubin =< ULN

- Gastrointestinal:

- Able to swallow tablets intact or dissolved in water;

- no dysphagia;

- no active gastrointestinal disease or disorder that would alter gastrointestinal
motility or absorption;

- no lack of integrity of the gastrointestinal tract

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior trastuzumab (Herceptin) or cetuximab

- No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy

- No other concurrent chemotherapy

- No concurrent hormonal therapy except for the following:

- hormones for non-disease-related conditions (e.g., insulin for diabetes);

- steroids for adrenal failure;

- intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel
hypersensitivity reactions

- At least 3 weeks since prior radiotherapy, including cranial irradiation

- No concurrent radiotherapy, including palliative radiotherapy

- At least 3 weeks since prior major surgery

- No prior significant surgical resection of the stomach or small bowel

- No prior erlotinib, gefitinib, or lapatinib

- No other prior treatment targeting the HER family axis

- More than 4 weeks since prior and no other concurrent investigational agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS) rate

Outcome Description:

The product limit estimator developed by Kaplan and Meier will be used to graphically describe progression free survival for patients randomized to each study arm.

Outcome Time Frame:

At 18 weeks

Safety Issue:

No

Principal Investigator

Pasi Janne

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00464

NCT ID:

NCT00126581

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Adenosquamous Cell Lung Cancer
  • Bronchoalveolar Cell Lung Cancer
  • Lung Cancer
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Roswell Park Cancer InstituteBuffalo, New York  14263
Rhode Island HospitalProvidence, Rhode Island  02903
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Memorial Hospital of South BendSouth Bend, Indiana  46601
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Franklin Square Hospital CenterBaltimore, Maryland  21237
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Brigham and Women's HospitalBoston, Massachusetts  02115
Elkhart General HospitalElkhart, Indiana  46515
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Saint Rose HospitalHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Mountainview MedicalBerlin, Vermont  05602
Highland General HospitalOakland, California  94602
Missouri Cancer AssociatesColumbia, Missouri  65201
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860
Lowell General HospitalLowell, Massachusetts  01854
Miriam HospitalProvidence, Rhode Island  02906
Washington Hospital CenterWashington, District of Columbia  20010
Saint Francis Medical CenterGrand Island, Nebraska  68802
McLeod Regional Medical CenterFlorence, South Carolina  29501
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
Rappahannock General HospitalKilmarnock, Virginia  22482
Cancer Care AssociatesTulsa, Oklahoma  74136
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
Holy Cross HospitalFort Lauderdale, Florida  33308
El Camino HospitalMountain View, California  94040
University of California at San DiegoLa Jolla, California  92093
South Shore HospitalSouth Weymouth, Massachusetts  02190
University Of VermontBurlington,, Vermont  05403
Kaiser PermanenteSacramento, California  
Ralph Lauren Center for Cancer Care and PreventionNew York, New York  10035
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
University of California San Diego - Veterans AdministrationSan Diego, California  92161
University of California San Francisco Medical Center-Mount ZionSan Francisco, California  94115
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Middlesex HospitalMiddletown, Connecticut  06457
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
Saint Joseph's Medical CenterSouth Bend, Indiana  46617
North Shore Medical Center Cancer CenterPeabody, Massachusetts  01960
Lakeland HospitalSt. Joseph, Michigan  49085
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Kinston Medical Specialists PAKinston, North Carolina  28501
Greenville Memorial HospitalGreenville, South Carolina  29605
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Jupiter Medical CenterJupiter, Florida  33458
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
University of Missouri - Ellis FischelColumbia, Missouri  65203
Veterans AdministrationColumbia, Missouri  65201
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Capital Regional Medical CenterJefferson City, Missouri  65101
Saint Joseph's Hospital Health CenterSyracuse, New York  13203
Saint Joseph HospitalNashua, New Hampshire  03060
Cancer and Leukemia Group BChicago, Illinois  60606
North Shore-LIJ Health System CCOPManhasset, New York  11030
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350