Clinical trial NCT00004011 (phase 3, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1
             of the following staging criteria:

               -  Stage IB (T2, N0)

               -  Stage II

                    -  T1-2, N1 with negative mediastinoscopy OR

                    -  T3, N0

               -  Selected stage IIIA with negative mediastinoscopies

                    -  T3, N1, excluding superior sulcus

                    -  Positive level 10 hilar nodes allowed if mediastinoscopy negative

          -  Apical tumors with no clinical symptoms allowed

          -  No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus

               -  No Pancoast's tumors

          -  Negative mediastinoscopy required in all patients with clinically positive mediastinal
             or hilar lymph nodes to ensure no N2 disease

          -  Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT
             scan

               -  T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers
                  and documented by photograph that includes main carina

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Zubrod 0 or 1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  WBC at least 4,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  SGOT or SGPT no greater than 2 times ULN

          -  Alkaline phosphatase no greater than 2 times ULN

        Renal:

          -  Creatinine no greater than 1.5 times ULN

          -  Creatinine clearance at least 50 mL/min

        Pulmonary:

          -  See Disease Characteristics

          -  Preresection FEV_1 greater than 2.0 L OR

          -  Predicted postresection FEV_1 greater than 1.0 L

          -  No postobstructive pneumonia

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No serious infection

          -  No other serious medical condition that would preclude study compliance

          -  No prior allergic reactions to drugs containing Cremophor

          -  No prior malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior systemic chemotherapy for NSCLC

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior systemic radiotherapy for NSCLC

          -  No concurrent radiotherapy

        Surgery:

          -  At least 5 years since prior resection of lung disease

        Other:

          -  No other concurrent investigational therapy

          -  No other concurrent anticancer therapy