Clinical trial NCT00554463 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: filgrastim, pegfilgrastim, etoposide, cisplatin
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, CN1[C@H]2CC[C@@H]1C[C@@H](C2)OC(=O)[C@H](CO)C1=CC=CC=C1, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell carcinoma of the lung

               -  Limited stage disease, defined as any of the following:

                    -  Tumor confined to one hemithorax

                    -  T4 tumor not based on malignant pleural effusion

                    -  N3 disease not based on contralateral supraclavicular involvement

          -  No complete tumor resection

          -  Measurable or evaluable disease

          -  Pleural effusion allowed provided the following conditions are present:

               -  Effusion is too small to tap under CT guidance and is not evident on chest x-ray

               -  Effusion appears only after a thoracotomy or other invasive procedure

          -  Must have certification by a Radiation Oncologist that the tumor can be encompassed by
             limited radiotherapy fields without significantly compromising pulmonary function

          -  No distant metastases

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  ANC (absolute neutrophil count) ≥ 1,800 cells/mm³

          -  Platelet count ≥ 100,000 cells/mm³

          -  Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
             g/dL allowed)

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 2 times the
             upper limit of normal (ULN)

          -  Alkaline phosphatase < 2.5 times ULN (< 5 times ULN if judged by the investigator to
             be related to liver metastases)

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Creatinine clearance ≥ 50 mL/min

          -  FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5
             liters/second

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 60 days after the
             last study treatment

          -  No prior invasive malignancy, except non-melanomatous skin cancer or other
             micro-invasive malignancy, or carcinoma in situ of the breast, oral cavity, or cervix,
             unless the patient has been disease-free for a minimum of 3 years

          -  No weight loss > 5% for any reason within the past 3 months

          -  No severe, active comorbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics

               -  Chronic Obstructive Pulmonary Disease exacerbation with FEV1 (forced expiratory
                  volume) < 1.5 liters/second or other respiratory illness requiring
                  hospitalization or precluding study therapy within the past 30 days

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

               -  AIDS (HIV testing not required for entry into this protocol)

          -  No prior allergic reaction to the study drugs

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for lung cancer

               -  Prior chemotherapy for a different cancer is allowed, provided it was completed ≥
                  5 years prior to registration

          -  No prior radiotherapy to the region of the study cancer that would result in overlap
             of radiotherapy fields

          -  No concurrent intensity-modulated radiotherapy

          -  No concurrent amifostine