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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

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