Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC; Gossypol; APE1; Chemotherapy
Brief summary
The investigators' experimental study found that gossypol was the natural inhibitor of apyrimidinic endonuclease 1 (APE1) and clinical study observed that high expression of APE1 was relative to the platinum-resistance in non-small cell lung cancer. Thus the purpose of this study is to find out whether gossypol can improve the sensitivity of cisplatin-based chemotherapy in the non-small cell lung cancer with apurinic apyrimidinic endonuclease 1 (APE1) high expression
Interventions
DRUGGossypol
DRUGPlacebo
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis of NSCLC, Stage IIIB/IV. * Males or females between 18 Years to 75 Years. * No prior cisplatin-based chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks. The interval for targeted therapy such as EGFR TKI is above 2 weeks. * Performance status of 0, 1 on the ECOG criteria. Expected survival is above three months. * At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000). * Patients can have the brain / meningeal metastasis history, but the metastasis must be treated by operation or radiotherapy), and clinically stable for at least 2 months. * Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function. * Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative. * APE1 IHC (++ or +++). * If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 2 months after trial. If male, use of an approved contraceptive method during the study and 2 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment. * No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
Exclusion criteria
* Inability to comply with protocol or study procedures. * Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease. * Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * Pregnant or breast-feeding. * Enrollment in other study within 30 days. * Brain metastasis with symptoms. * Hypokalemic periodic paralysis history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | the first day of treatment to the date that disease progression is reported; assesed up to 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | the first day of treatment to death or last survival confirm date; assesed up to 4 years | — |
| Tumor response rate | Up to 4 years | The ratio between the number of responders and number of patients assessable for tumor response |
| Toxicity | the first date of treatment to 30 days after the last dose of study drug | Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Quality of life | the day before every cycle of chemotherapy; 30 days after the last dose of study drug | — |
Countries
China
Contacts
Primary ContactDong Wang, PH.D.
Outcome results
None listed