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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192243
First received: August 4, 2010
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

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).


Condition Intervention Phase
Toxicity
Non-small Cell Lung Cancer
Drug: Gefitinib
Drug: Pemetrexed
Drug: Cisplatin or carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • response rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to NCI CTC V3.0

  • Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to FACT-LCS scores


Estimated Enrollment: 68
Study Start Date: December 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gefitinib
    250mg qd po d3-16
    Drug: Pemetrexed
    500mg/m2 venous infusion,D1,q3w
    Drug: Cisplatin or carboplatin
    Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01192243

Contacts
Contact: Jianhua chang, MD,PHD 13916619284 changjianhua@hotmail.com

Locations
China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianhua Chang, MD,PhD    13916619284    changjianhua@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT01192243     History of Changes
Other Study ID Numbers: Iressa combined with Pem/Cis
Study First Received: August 4, 2010
Last Updated: September 2, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Objective response rate
Time to Progression
Quality of Live

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cisplatin
Gefitinib
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014