Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression
- Registration Number
- NCT01977209
- Lead Sponsor
- Third Military Medical University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 204
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Gossypol Docetaxel 75mg/m2/iv over 90min and cisplatin 75mg/m2/iv over 90min on day 1. Gossypol 20mg from day 1 to day 14. repeat Q 3weeks. Four cycles. Arm B Placebo Docetaxel 75mg/m2/iv over 90min and cisplatin 75mg/m2/iv over 90min on day 1. Placebo from day 1 to day 14. repeat Q 3weeks. Four cycles.
- Primary Outcome Measures
Name Time Method Progression-free survival the first day of treatment to the date that disease progression is reported; assesed up to 4 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Chongqing Zhongshan Hospital
🇨🇳Chongqing, Chongqing, China
Jiangjin Central Hospital
🇨🇳Chongqing, Chongqing, China
Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Fuling Central Hospital
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Medical University Of Chongqing
🇨🇳Chongqing, Chongqing, China