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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 Center New York, New York  10021
Roswell Park Cancer Institute Buffalo, New York  14263
Rhode Island Hospital Providence, Rhode Island  02903
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Memorial Hospital of South Bend South Bend, Indiana  46601
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Franklin Square Hospital Center Baltimore, Maryland  21237
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Long Island Jewish Medical Center New Hyde Park, New York  11040
Brigham and Women's Hospital Boston, Massachusetts  02115
Elkhart General Hospital Elkhart, Indiana  46515
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Saint Rose Hospital Hayward, California  94545
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Great Plains Regional Medical Center North Platte, Nebraska  69101-6598
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Mountainview Medical Berlin, Vermont  05602
Highland General Hospital Oakland, California  94602
Missouri Cancer Associates Columbia, Missouri  65201
Center for Cancer Care and Research St. Louis, Missouri  63141
Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860
Lowell General Hospital Lowell, Massachusetts  01854
Miriam Hospital Providence, Rhode Island  02906
Washington Hospital Center Washington, District of Columbia  20010
Saint Francis Medical Center Grand Island, Nebraska  68802
McLeod Regional Medical Center Florence, South Carolina  29501
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
Rappahannock General Hospital Kilmarnock, Virginia  22482
Cancer Care Associates Tulsa, Oklahoma  74136
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Larry G Strieff MD Medical Corporation Oakland, California  94609
Holy Cross Hospital Fort Lauderdale, Florida  33308
El Camino Hospital Mountain View, California  94040
University of California at San Diego La Jolla, California  92093
South Shore Hospital South Weymouth, Massachusetts  02190
University Of Vermont Burlington,, Vermont  05403
Kaiser Permanente Sacramento, California  
Ralph Lauren Center for Cancer Care and Prevention New York, New York  10035
Memorial Health University Medical Center Savannah, Georgia  31404
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Valley Medical Oncology Consultants-Castro Valley Castro Valley, California  94546
Eden Hospital Medical Center Castro Valley, California  94546
Valley Medical Oncology Consultants-Fremont Fremont, California  94538
Bay Area Breast Surgeons Inc Oakland, California  94609
Bay Area Tumor Institution CCOP Oakland, California  94609
Tom K Lee Inc Oakland, California  94609
Valley Medical Oncology Consultants Pleasanton, California  94588
Valley Care Health System - Pleasanton Pleasanton, California  94588
University of California San Diego - Veterans Administration San Diego, California  92161
University of California San Francisco Medical Center-Mount Zion San Francisco, California  94115
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo, California  94806
Middlesex Hospital Middletown, Connecticut  06457
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
Saint Joseph's Medical Center South Bend, Indiana  46617
North Shore Medical Center Cancer Center Peabody, Massachusetts  01960
Lakeland Hospital St. Joseph, Michigan  49085
Missouri Baptist Medical Center Saint Louis, Missouri  63131
State University of New York Upstate Medical University Syracuse, New York  13210
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Kinston Medical Specialists PA Kinston, North Carolina  28501
Greenville Memorial Hospital Greenville, South Carolina  29605
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
Jupiter Medical Center Jupiter, Florida  33458
Mount Sinai Medical Center CCOP Miami Beach, Florida  33140
University of Missouri - Ellis Fischel Columbia, Missouri  65203
Veterans Administration Columbia, Missouri  65201
University of Minnesota Medical Center-Fairview Minneapolis, Minnesota  55455
Capital Regional Medical Center Jefferson City, Missouri  65101
Saint Joseph's Hospital Health Center Syracuse, New York  13203
Saint Joseph Hospital Nashua, New Hampshire  03060
Cancer and Leukemia Group B Chicago, Illinois  60606
North Shore-LIJ Health System CCOP Manhasset, New York  11030
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350