AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer; Lung Metastases; Malignant Pleural Effusion; Recurrent Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Pleural Effusion, Malignant; Pleural Effusion
Intervention: saracatinib
Intervention description: Given orally
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. This phase II study is studying how well giving AZD0530 works in treating patients
      with extensive-stage small cell lung cancer.
    

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