S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin; gemcitabine hydrochloride
Intervention description: Given IV; Given IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after
      surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses.
      In this case, observation may be sufficient.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin
      works in treating patients with stage I non-small cell lung cancer that was removed by
      surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer

               -  Stage IA (longest tumor diameter 2-3 cm) or stage IB disease

          -  Must have undergone preoperative CT scan of the chest (including the entire liver and
             adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no
             evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery

          -  A whole body PET scan or a combined PET/CT must be performed within 84 days

               -  Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must
                  have been cleared by further evaluation, including, but not limited to, any of
                  the following:

                    -  Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear
                       medicine imaging

          -  Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed
             by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days

               -  Completely excised primary lesion with negative gross and microscopic margins

               -  At least two mediastinal lymph node stations sampled

          -  Must have tumor tissue available from the surgical resection specimen AND agree to
             have treatment assignment determined by a gene expression analysis performed on that
             tissue

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 10 mg/dL

          -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 1.5 times ULN

          -  Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other prior malignancy except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  In situ cervical cancer

               -  Adequately treated stage I-II cancer from which the patient is currently in
                  complete remission

               -  Any other cancer from which the patient has been disease-free for 5 years

          -  Willing to provide prior smoking history

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior systemic chemotherapy or biologic therapy for lung cancer

          -  No prior thoracic radiation therapy (RT) (including RT to the chest wall)

          -  No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal
             therapy

               -  Steroids administered for antiemesis, adrenal failure, or septic shock OR
                  hormones administered for non-disease-related conditions (e.g., insulin for
                  diabetes) allowed