Trial | NCT01836679  Report issue

Title

Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    124
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
Study Started
Apr 30
2013
Primary Completion
May 31
2015
Study Completion
Dec 31
2015
Last Update
Feb 01
2016
Estimate

Drug Chidamide

Given orally

  • Other names: CS055

Drug Paclitaxel

Given IV

  • Other names: TAX, Taxol

Drug Carboplatin

Given IV

  • Other names: CBDCA, Paraplatin

Drug Placebo

Given orally

  • Other names: PLB

Arm 1 Experimental

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.

Arm 2 Placebo Comparator

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.

Criteria 

Inclusion Criteria:

Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
Aged 18~75 years
Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
With at least one measurable lesion
White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
Life expectancy >3 months
Eastern Cooperative Oncology Group performance status of ≤1 at study entry
Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
Have signed informed consent

Exclusion Criteria:

Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
Organ transplant patients
Patients with active bleeding or new thrombotic diseases
Patients with body temperature >38.5℃ for more than 3 days
Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN
Patients with symptomatic brain-metastasis
Pregnant or lactating women
Patients with mental disorder
No Results Posted