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ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ABX Combined With Cisplatin
Gemcitabine Combined With Cisplatin
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring PFS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

1.18~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values:

  • leucocyte ≥ 4×109/L
  • neutrophil ≥ 1.5×109/L
  • platelet ≥ 100×109/L
  • Hemoglobin ≥ 10g/L
  • ALT and
  • AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent

Exclusion Criteria:

  • Patients have used drugs according to protocol
  • Patients were allergic to pemetrexed or cisplatin
  • Patients received radiotherapy or other biological treatment 4 weeks before the trial
  • Uncontrolled hydrothorax or hydropericardium
  • neuropathy toxicity ≥ CTC 3
  • Severe symptomatic heart disease
  • Active upper gastrointestinal ulcer or digestive disfunction
  • Severe infection or metabolic disfunction
  • Patients with other malignant tumor
  • Uncontrolled brain metastases
  • Patients have accepted other clinical trials
  • Female patients during their pregnant and lactation period, or patients without contraception

Sites / Locations

  • Cancer hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABX Combined With Cisplatin

Gemcitabine Combined With Cisplatin

Arm Description

ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt

gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

First Posted
March 11, 2013
Last Updated
February 22, 2016
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01810367
Brief Title
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Official Title
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
PFS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABX Combined With Cisplatin
Arm Type
Experimental
Arm Description
ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt
Arm Title
Gemcitabine Combined With Cisplatin
Arm Type
Active Comparator
Arm Description
gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
Intervention Type
Drug
Intervention Name(s)
ABX Combined With Cisplatin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Combined With Cisplatin
Primary Outcome Measure Information:
Title
PFS
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1.18~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values: leucocyte ≥ 4×109/L neutrophil ≥ 1.5×109/L platelet ≥ 100×109/L Hemoglobin ≥ 10g/L ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent Exclusion Criteria: Patients have used drugs according to protocol Patients were allergic to pemetrexed or cisplatin Patients received radiotherapy or other biological treatment 4 weeks before the trial Uncontrolled hydrothorax or hydropericardium neuropathy toxicity ≥ CTC 3 Severe symptomatic heart disease Active upper gastrointestinal ulcer or digestive disfunction Severe infection or metabolic disfunction Patients with other malignant tumor Uncontrolled brain metastases Patients have accepted other clinical trials Female patients during their pregnant and lactation period, or patients without contraception
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

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