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Phase II Trial Of OSI-774 (NSC-718781) In Patients With Advanced Non-Small Cell Lung Cancer And A Performance Status Of 2

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer.

Date & Status


Who can Participate?


18 and older




- Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)
meeting 1 of the following stage criteria:

- Selected stage IIIB disease (excluding Pancoast tumors)

- T4 lesion due to malignant pleural effusion only

- Any N

- M0

- Stage IV disease

- Any T

- Any N

- M1

- Recurrent disease after prior surgery and/or radiotherapy

- The following histologies are eligible:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified

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

- Measurable disease must be outside prior irradiated fields OR a new lesion must
be present

- Measurable disease must be outside the area of prior surgical resection

- No brain metastases

- Negative CT scan or MRI if there are neurological abnormalities on physical exam
or symptoms

- Patients must be offered participation in protocol SWOG-S9925 (Lung Cancer Specimen
Repository study)



- 18 and over

Performance status

- Zubrod 2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:

- Alkaline phosphatase ≤ ULN AND SGOT OR SGPT ≤ 2 times ULN

- Alkaline phosphatase ≤ 4 times ULN AND SGOT OR SGPT ≤ ULN


- Creatinine ≤ 2 mg/dL


- No significant history of cardiac disease

- No uncontrolled high blood pressure

- No unstable angina

- No congestive heart failure

- No cardiac ventricular arrhythmias requiring medication

- No myocardial infarction within the past 6 months


- No GI tract disease resulting in an inability to take oral medication

- No malabsorption syndrome

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

- No requirement for IV alimentation


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission


Biologic therapy

- No prior biologic therapy for NSCLC

- No concurrent biologic therapy


- No prior systemic chemotherapy for NSCLC

Endocrine therapy

- No prior hormonal therapy for NSCLC

- No concurrent hormonal therapy


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy to measurable or non-measurable lesions

- Concurrent palliative radiotherapy to small-field non-measurable sites of
painful bony metastases allowed provided there are other sites of measurable
disease outside of the radiotherapy treatment field


- See Disease Characteristics

- At least 3 weeks since prior thoracic or other major surgeries and recovered

- No prior surgical procedures affecting gastrointestinal (GI) absorption


- No prior epidermal growth factor receptor inhibitors

Gender: Both
Steward Physician(s)
  • Paul J. Hesketh, MD
  • Antoinette J. Wozniak, MD
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
  • erlotinib hydrochloride
Physician Researcher

Investigator Name:

  • Paul J. Hesketh, MD
  • Antoinette J. Wozniak, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00087412
Volunteers:  Not Accepting Healthy Volunteers

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