NCT01977209|UnknownPhase 3DMC

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

GTCA

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

Third Military Medical University ClinicalTrials.gov

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1 other identifier

GTCA

Study Type

interventional

Target

204

Locations

1 country

Sites

Timeline

RegisteredNov 2013

StartedSep 2013

CompletionSep 2016

Brief 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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

204

participants targeted

Target at below P25 for phase_3 nonsmall-cell-lung-cancer

Timeline

Completed

Started Sep 2013

Shorter than P25 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

1 country

6 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

September 1, 2013

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2013

Completed

18 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

2.4 years

First QC Date

October 19, 2013

Last Update Submit

October 30, 2013

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Gossypol; APE1; Chemotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Overall survival
the first day of treatment to death or last survival confirm date; assesed up to 4 years
Tumor response rate
Up to 4 years
Toxicity
the first date of treatment to 30 days after the last dose of study drug
Quality of life
the day before every cycle of chemotherapy; 30 days after the last dose of study drug

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

PLACEBO COMPARATOR

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

Interventions

GossypolDRUG

Arm A

PlaceboDRUG

Arm B

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Third Military Medical Universitylead

Study Sites (6)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Chongqing Zhongshan Hospital