Clinical trial NCT00528645 (phase 2, status: completed)
Conditions: extensive stage small cell lung cancer, lung metastases, malignant pleural effusion, recurrent small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: saracatinib
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed small cell lung cancer

               -  No mixed histology

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

               -  Metastatic disease outside the chest

               -  Contralateral supraclavicular nodes or contralateral hilar nodes that cannot be
                  included in a single radiation port

               -  Cytologically confirmed malignant pleural effusion

                    -  Clinically significant effusions (e.g., symptomatic pleural effusion) must
                       be drained prior to treatment

          -  Previously untreated disease* OR stable disease, partial response, or complete
             response ≤ 4 weeks after completion of one course (four 3-week courses) of standard
             platinum-based chemotherapy

          -  No symptomatic, untreated, or uncontrolled CNS metastases

               -  CNS metastases previously treated with whole brain radiotherapy allowed

          -  ECOG performance status (PS) 0-2

          -  Life expectancy ≥ 12 weeks

          -  WBC ≥ 3,000/mm³

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin > 9.0 g/dL

          -  Total bilirubin < 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN

          -  ALT and AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

          -  Proteinuria ≤ +1 on two consecutive dipsticks taken no less than 24hours apart

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective protection during and for up to 8 weeks after
             completion of study therapy

          -  QTc interval ≤ 460 msec

          -  No seizure disorder

          -  No significant traumatic injury ≤ 4 weeks prior to registration

          -  No clinically significant infection

          -  No HIV-positivity

          -  No second primary malignancy, except for carcinoma in situ of the cervix or
             nonmelanoma skin cancer, unless prior malignancy was diagnosed and treated ≥ 5 years
             with no subsequent evidence of recurrence

               -  Patients with a history of low grade(Gleason score ≤ 6) localized prostate cancer
                  will be eligible even if diagnosed < 5 years prior to registration

          -  No concurrent severe and/or uncontrolled medical conditions, including any of the
             following:

               -  Cardiac arrhythmias

               -  Angina pectoris uncontrolled with medication

               -  Myocardial infarction within the past 3 months

               -  Significant ECG abnormalities

               -  Hypertension, labile hypertension, or history of poor compliance with
                  anti-hypertensive medication

               -  Congestive heart failure within the past 3 months, unless ejection fraction > 40%

               -  Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the
                  lung

               -  Poorly controlled diabetes

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to AZD0530

          -  No condition that impairs the ability to swallow AZD0530 tablets, including any of the
             following:

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or requiring IV alimentation

               -  Prior surgical procedures affecting absorption of AZD0530 tablets

               -  Active peptic ulcer disease

          -  No serious condition that, in the opinion of the investigator, would compromise the
             patient's ability to complete the study

          -  At least 4 weeks since prior major surgery (i.e., laparotomy) or open biopsy

          -  At least 2 weeks since prior minor surgery

          -  At least 4 weeks since any prior investigational ancillary therapy (i.e., utilized for
             a non-FDA-approved indication and in the context of a research investigation)

          -  At least 7 days since prior use of strong inhibitors of CYP3A4 and no concurrent use
             for up to 7 days after discontinuation of AZD0530

          -  Prior nonthoracic palliative radiotherapy allowed

          -  Concurrent bisphosphonates for treatment of lytic metastatic bone disease allowed at
             the discretion of the treating physician

          -  No concurrent prophylactic granulocyte colony-stimulating factor (i.e., G-CSF)

          -  No concurrent products that stimulate thrombopoiesis

          -  No concurrent St. John's wort

          -  No other concurrent chemotherapy, immunotherapy, hormonal therapy,or radiotherapy