Clinical trial NCT00445848 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

               -  Adenocarcinoma

                    -  No component of squamous cell carcinoma present

               -  Incompletely resected or unresectable disease

          -  Stage IIIB or IV disease as defined below:

               -  Selected stage IIIB disease

                    -  T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci
                       that are separate from direct pleural invasion by the primary tumor)

                    -  Any N

                    -  M0

               -  Stage IV disease

                    -  Any T

                    -  Any N

                    -  M1 (distant metastases present)

                    -  Recurrent lung cancer in a separate lobe after resection or radiotherapy
                       within the past 5 years OR multifocal lesions in > 1 lobe considered stage
                       IV disease

          -  New lesions occurring ≥ 5 years after resection may be considered a separate primary
             cancer and are not allowed if this is the only focus of lung cancer

          -  Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan,
             or MRI

               -  Disease must be present outside a previous radiotherapy field OR a new lesion
                  must be inside the port

               -  Measurable disease must be assessed within the past 28 days

               -  Nonmeasurable disease must be assessed within the past 42 days

               -  Pleural effusions, ascites, and laboratory parameters are not acceptable as the
                  only evidence of disease

          -  Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)

          -  Treated brain metastases allowed provided the patient is asymptomatic and do not
             require steroids

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin normal

          -  SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
             present)

          -  Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

          -  Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine
             collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Hypertension allowed if controlled on medication prior to study enrollment

          -  Must be willing to provide prior smoking history

          -  No immediate life-threatening complications from malignancies

          -  No prior major medical condition, psychological condition, or social situation that
             would preclude study treatment

          -  No hemoptysis ≥ ½ teaspoon within the past 28 days

          -  No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the
             past 6 months or grade 1 within the past 28 days

          -  No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic
             stroke, or other CNS bleeding

          -  No serious nonhealing wound, ulcer, or bone fracture

          -  No other prior malignancy except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Adequately treated stage I or II cancer from which the patient is currently in
                  complete remission

               -  In situ cervical cancer

               -  Any other cancer from which the patient has been disease-free for 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 7 days since prior fine-needle aspiration or core biopsy

          -  At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and
             recovered

          -  At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and
             recovered

          -  At least 28 days since prior systemic chemotherapy

          -  Prior biologic therapy allowed

          -  No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies
             against the epidermal growth factor receptor or vascular endothelial growth factor
             axes

          -  Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low
             molecular weight heparin), provided the patient has no history of bleeding
             complications on anticoagulation or an inability to establish a stable therapeutic
             regimen for anticoagulation

          -  No concurrent surgery

          -  No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy,
             biological therapy, or radiotherapy) directed at this cancer