AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Extensive Stage Small Cell Lung Cancer, Lung Metastases, Malignant Pleural Effusion, Recurrent Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00528645
- Run by
- National Cancer Institute (NCI)
- People needed
- 23
- Starts
- 2007-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-12-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- North Central Cancer Treatment Group — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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