S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboplatin; erlotinib hydrochloride; paclitaxel
Intervention description: given IV; given orally; given IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  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
             scan

               -  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
                  registration

        PATIENT CHARACTERISTICS:

          -  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
             medication

          -  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

        PRIOR CONCURRENT THERAPY:

          -  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
             NSCLC

          -  No prior EGFR inhibitors

          -  No prior surgical procedures affecting absorption

          -  No concurrent major surgery