Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Bevacizumab, gemcitabine, cisplatin, EGFR wild-type
Eligibility Criteria
Inclusion Criteria:
- Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation Negative.
- Stage IIIB/IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system
- Not received radiotherapy, chemotherapy or other biological treatment
- Measureable disease
- Life expectancy of >= 12 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Absolute neutrophil count (ANC) >= 2, 500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9.0 g/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases
- Cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN
- Prothrombin time (PT) =< 1.5 x ULN
- Partial thromboplastin time (PTT) =< ULN
- Urine dipstick proteinuria < 2+ * Note: Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours
- Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
- Provide informed written consent
- Willing to return to Sichuan cancer hospital for follow-up
- Willing to provide tissue and blood samples for correlative research purposes
Exclusion Criteria:
- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- Prior chemotherapy or treatment for metastatic non-small cell lung cancer
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =< 3 years prior to randomization; EXCEPTIONS: Non melanotic skin cancer or carcinoma-in-situ of the cervix
- History of myocardial infarction or other evidence of arterial thrombotic disease (angina)
- History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =< 6 months prior to randomization
- Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
- History of bleeding diathesis or coagulopathy
- Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 100 mmHg on anti-hypertensive medications)
- Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury =< 28 days or core biopsy =< 7 days prior to randomization
- History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess =< 6 months prior to randomization
- History of hemoptysis >= grade 2 (defined as bright red blood of at least 2.5 mL) =< 3 months prior to randomization
- Pregnancy
Sites / Locations
- Sichuan Cancer Hospital
- Sichuan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I: bevacizumab plus chemotherapy
Arm II: chemotherapy
Patients in the experimental arm receive cisplatin and gemcitabine combination with Bevacizumab. GP chemotherapy (gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) plus bevacizumab (7.5 mg/kg IV on D1 of every 21-day cycle).
Patients receive gemcitabine combined with cisplatin chemotherapy((gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) ) every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.