Trial Title:
Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression
NCT ID:
NCT01977209
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Gossypol
Conditions: Keywords:
NSCLC; Gossypol; APE1; Chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Gossypol
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Placebo
Arm group label:
Arm B
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Daping Hospital, Third Military Medical University
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Wang, PH.D.
Phone:
86-23-68757151
Email:
dongwang64@hotmail.com
Investigator:
Last name:
Dong Wang, PH.D.
Email:
Principal Investigator
Facility:
Name:
Chongqing Zhongshan Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhixiang Yang, M.D.
Phone:
13032372491
Investigator:
Last name:
Zhixiang Yang
Email:
Principal Investigator
Facility:
Name:
Fuling Central Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Qi Zhou, M.D.
Phone:
86-23-7222676
Investigator:
Last name:
Qi Zhou, M.D.
Email:
Principal Investigator
Facility:
Name:
Jiangjin Central Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Debing Xiang, M.D.
Phone:
86-13320336639
Investigator:
Last name:
Debing Xiang, M.D.
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Medical University Of Chongqing
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianquan Zhang, M.D.
Phone:
86-23-63693000
Investigator:
Last name:
Xianquan Zhang, M.D.
Email:
Principal Investigator
Facility:
Name:
Three Gorges Central Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Biyong Ren
Phone:
13896327099
Investigator:
Last name:
Biyong Ren, M.D.
Email:
Principal Investigator
Start date:
September 2013
Completion date:
September 2016
Lead sponsor:
Agency:
Third Military Medical University
Agency class:
Other
Source:
Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01977209
