Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

February 22, 2016 updated by: Chang Jian Hua, Fudan University

Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized to 2 groups

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2
  • 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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Cancer hospital Fudan University

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18~70 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
Drug: Sequential Gefitinib With Pemetrexed/Platinum
Active Comparator: Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1
Drug: Pemetrexed/Platinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12 weeks of non-progression rate
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Chang jian hua, MD,PhD, Cancer hospital Fudan University

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

December 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 16, 2013

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gefitinib-2009-cjh

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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