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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University
ClinicalTrials.gov Identifier:
NCT01769066
First received: January 10, 2013
Last updated: May 12, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
NSCLC
Drug: Sequential Gefitinib With Pemetrexed/Platinum
Drug: Pemetrexed/Platinum
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 12 weeks of non-progression rate [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: December 2009
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Patients will be randomized to 2 groups

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769066

Locations
China, Shanghai
Cancer hospital Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Chang jian hua, MD,PhD Cancer hospital Fudan University
  More Information

No publications provided

Responsible Party: Chang Jian Hua, Deputy director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT01769066     History of Changes
Other Study ID Numbers: Gefitinib-2009-cjh
Study First Received: January 10, 2013
Last Updated: May 12, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Pemetrexed
Gefitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014