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Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
NSCLC; Gossypol; APE1; Chemotherapy
Study Type
Interventional
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
Intervention
Name: Gossypol
Type: Drug
Name: Placebo
Type: Drug
Overall Status
Recruiting
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
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.
- 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.
Locations
Chongqing Zhongshan Hospital
Chongqing, Chongqing, China
Daping Hospital, Third Military Medical University
Status: Recruiting
Contact: Zhixiang Yang, M.D. - 13032372491
Chongqing, Chongqing, China
Fuling Central Hospital
Status: Recruiting
Contact: Dong Wang, PH.D. - 86-23-68757151 - dongwang64@hotmail.com
Chongqing, Chongqing, China
Jiangjin Central Hospital
Status: Recruiting
Contact: Qi Zhou, M.D. - 86-23-7222676
Chongqing, Chongqing, China
The Second Affiliated Hospital of Medical University Of Chongqing
Status: Recruiting
Contact: Debing Xiang, M.D. - 86-13320336639
Chongqing, Chongqing, China
Three Gorges Central Hospital
Status: Recruiting
Contact: Xianquan Zhang, M.D. - 86-23-63693000
Chongqing, Chongqing, China
Status: Recruiting
Contact: Biyong Ren - 13896327099
Start Date
September 2013
Completion Date
September 2016
Sponsors
Third Military Medical University
Source
Third Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page