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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 Perfor

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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 some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Date & Status


Who can Participate?


18 and older




- 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

- 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


- 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

- 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


- 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

- No prior EGFR inhibitors

- No prior surgical procedures affecting absorption

- No concurrent major surgery

Gender: Both
Steward Physician(s)
  • Primo N. Lara, MD
  • Paul J. Hesketh, MD
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
  • carboplatin
  • erlotinib hydrochloride
  • paclitaxel
For more information about this trial, contact

Leslie A. Martin, MD

Phone: (617) 789-2903

Physician Researcher

Investigator Name:

  • Primo N. Lara, MD
  • Paul J. Hesketh, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00661193
Volunteers:  Not Accepting Healthy Volunteers

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