Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
NSCLC; Gossypol; APE1; Chemotherapy
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Name: Gossypol Type: Drug
Name: Placebo Type: Drug
Overall Status
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Chongqing Zhongshan Hospital
Chongqing, Chongqing, China
Status: Recruiting
Contact: Zhixiang Yang, M.D. - 13032372491
Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China
Status: Recruiting
Contact: Dong Wang, PH.D. - 86-23-68757151 - dongwang64@hotmail.com
Fuling Central Hospital
Chongqing, Chongqing, China
Status: Recruiting
Contact: Qi Zhou, M.D. - 86-23-7222676
Jiangjin Central Hospital
Chongqing, Chongqing, China
Status: Recruiting
Contact: Debing Xiang, M.D. - 86-13320336639
The Second Affiliated Hospital of Medical University Of Chongqing
Chongqing, Chongqing, China
Status: Recruiting
Contact: Xianquan Zhang, M.D. - 86-23-63693000
Three Gorges Central Hospital
Chongqing, Chongqing, China
Status: Recruiting
Contact: Biyong Ren - 13896327099
Start Date
September 2013
Completion Date
September 2016
Third Military Medical University
Third Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page