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Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Primary Purpose

Toxicity, Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gefitinib
Pemetrexed
Cisplatin or carboplatin
Sponsored by
Fudan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxicity focused on measuring Objective response rate, Time to Progression, Quality of Live

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Age from 18 to 70 years old
  • At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
  • ECOG 0-1
  • Expected life time longer than 12 weeks
  • 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)

Exclusion Criteria:

  • Patients have not 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 UniversityRecruiting

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

Number of Participants with Adverse Events
according to NCI CTC V3.0
Progression free survival
quality of life
according to FACT-LCS scores

Full Information

First Posted
August 4, 2010
Last Updated
September 2, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01192243
Brief Title
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Official Title
Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxicity, Non-small Cell Lung Cancer
Keywords
Objective response rate, Time to Progression, Quality of Live

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Description
250mg qd po d3-16
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500mg/m2 venous infusion,D1,q3w
Intervention Type
Drug
Intervention Name(s)
Cisplatin or carboplatin
Intervention Description
Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w
Primary Outcome Measure Information:
Title
response rate
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
according to NCI CTC V3.0
Time Frame
six weeks
Title
Progression free survival
Time Frame
six weeks
Title
quality of life
Description
according to FACT-LCS scores
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer Age from 18 to 70 years old At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools ECOG 0-1 Expected life time longer than 12 weeks 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) Exclusion Criteria: Patients have not 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua chang, MD,PHD
Phone
13916619284
Email
changjianhua@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Chang, MD,PhD
Organizational Affiliation
Fudan University affiliated cancer hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chang, MD,PhD
Phone
13916619284
Email
changjianhua@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

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