Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression (GTCA)

October 30, 2013 updated by: Dong Wang, Third Military Medical University

A Randomized, Double Blind, Placebo-controlled Multiple-center Phase III Trial of Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Daping Hospital, Third Military Medical University
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Zhongshan Hospital
        • Contact:
          • Zhixiang Yang, M.D.
          • Phone Number: 13032372491
        • Principal Investigator:
          • Zhixiang Yang
      • Chongqing, Chongqing, China
        • Recruiting
        • Fuling Central Hospital
        • Contact:
          • Qi Zhou, M.D.
          • Phone Number: 86-23-7222676
        • Principal Investigator:
          • Qi Zhou, M.D.
      • Chongqing, Chongqing, China
        • Recruiting
        • Jiangjin Central Hospital
        • Contact:
          • Debing Xiang, M.D.
          • Phone Number: 86-13320336639
        • Principal Investigator:
          • Debing Xiang, M.D.
      • Chongqing, Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Medical University Of Chongqing
        • Contact:
          • Xianquan Zhang, M.D.
          • Phone Number: 86-23-63693000
        • Principal Investigator:
          • Xianquan Zhang, M.D.
      • Chongqing, Chongqing, China
        • Recruiting
        • Three Gorges Central Hospital
        • Contact:
          • Biyong Ren
          • Phone Number: 13896327099
        • Principal Investigator:
          • Biyong Ren, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
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.
Drug: Gossypol
Placebo Comparator: Arm B
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.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: the first day of treatment to the date that disease progression is reported; assesed up to 4 years
the first day of treatment to the date that disease progression is reported; assesed up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: the first day of treatment to death or last survival confirm date; assesed up to 4 years
the first day of treatment to death or last survival confirm date; assesed up to 4 years
Tumor response rate
Time Frame: Up to 4 years
The ratio between the number of responders and number of patients assessable for tumor response
Up to 4 years
Toxicity
Time Frame: 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.
the first date of treatment to 30 days after the last dose of study drug
Quality of life
Time Frame: the day before every cycle of chemotherapy; 30 days after the last dose of study drug
the day before every cycle of chemotherapy; 30 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Dong Wang, PH.D., Cancer Center, Daping Hospital, Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

October 19, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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