Non-small cell lung cancer
Conditions
Interventions
A:1st period, reference formulation 30mg/m2, 2nd period test formulation 30mg/m2
B:1st period test formulation 30mg/m2, 2nd period reference formulation 30mg/m2
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
54 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Eligible patients had histologically or cytologically confirmed, locally advanced (stage IIIB) or metastatic (stage IV) non-small-cell lung cancer; (2) Aged 18-70years; (3) patients must have discontinued all cancer therapies at least 4 weeks before study enrollmen; (4) patients have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST); (5) They needed to have measurable disease with a life expectancy of at least 3 months; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (7) non-drug abusers; (8) Vonlunteers could communicate well with the researchers and comply with the requirements of the entire study; (9) Subjects should have a strong understand of the object?nature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) the presence of the activity of viral hepatitis infection; (2) The persons allergy for investigator product or ingredients of investigator product; (3) Immunocompromised patients, including patients known to be HIV positive,or patients have a history of organ transplantation; (4) an absolute neutrophil count (ANC) of 2.5*ULN or in case of liver metastases >5*ULN and Serum bilirubin >5*ULN; (6) Creatinine clearance less than 80 ml/min, according to the formula Cault Cockcroft: [(140 - age) * weight (kg)] / [72 * serum creatinine (mg/dL)]; (7) temperature above 38 ? or has obvious infection; (8) patients had a history of central nervous system metastasis; (9) Suffering clinical severe cardiovascular disease or prolonged QTc interval; (10) Calcium, potassium and magnesium ions is lower than the normal lower limit; (11) peripheral neuropathy was greater than grade I; (12) Subects did not recovery from toxicities of all previous therapies for NSCLC; (13) Subjects with a history of bone metastasis were on concomitant palliative radiotherapy; (14) subjects had clinically uncontrolled pathergasiology,nervous,cardiac or respiratory system disease; (15) Subjects had a history of asthma; (16) Subects were pregnant or lactating.
Countries
China
Contacts
Public ContactJianzhong Shen-tu
Outcome results
None listed