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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
Open (Enrolling)
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

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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


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.


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

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

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:


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:


Principal Investigator

Pasi Janne

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




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



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