Malignant Pleural Effusion Clinical Trial
Official title:
Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma
Verified date | November 2017 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | May 2013 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | North Central Cancer Treatment Group | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival Rate at 12 Weeks | The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline. |
12 weeks | |
Secondary | Overall Survival | Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. | From registration to death due to any cause, assessed up to 2 years | |
Secondary | Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) | Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart.. | After every other 21-day cycle, up to 2 years. | |
Secondary | Progression Free Survival | Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier. | From registration to documentation of disease progression or death, assessed up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT06421610 -
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
|
Phase 1 | |
Recruiting |
NCT04793607 -
Interventions for Malignant Pleural Effusions Impact on Fatigue
|
||
Recruiting |
NCT03987087 -
A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC
|
Phase 2 | |
Recruiting |
NCT02942043 -
Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT01997190 -
Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
|
Phase 1 | |
Completed |
NCT00564733 -
FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04131231 -
Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
|
N/A | |
Completed |
NCT02674243 -
Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion
|
Phase 3 | |
Terminated |
NCT01004510 -
Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT00313066 -
Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion
|
Phase 4 | |
Terminated |
NCT04236037 -
Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura
|
N/A | |
Completed |
NCT05372055 -
Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
|
||
Not yet recruiting |
NCT04914598 -
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
|
Phase 3 | |
Recruiting |
NCT04322136 -
AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion
|
N/A | |
Recruiting |
NCT03973957 -
Talc Outpatient Pleurodesis With Indwelling Catheter
|
N/A | |
Recruiting |
NCT05923515 -
A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
|
Phase 1 | |
Completed |
NCT02649894 -
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
|
N/A | |
Recruiting |
NCT03403855 -
Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients
|
N/A | |
Terminated |
NCT03597009 -
A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion
|
Phase 1/Phase 2 |