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

NCT01192243 | Unknown Phase 2 DMC

• 1 other identifier: Iressa combined with Pem/Cis
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Toxicity; Non-small Cell Lung Cancer

Keywords

Objective response rate; Time to Progression; Quality of Live

Outcome Measures

Primary Outcomes (1)

• response rate

  six weeks

Secondary Outcomes (3)

• Number of Participants with Adverse Events

  six weeks

• Progression free survival

  six weeks

• quality of life

  six weeks

Interventions

Gefitinib DRUG

250mg qd po d3-16

Pemetrexed DRUG

500mg/m2 venous infusion,D1,q3w

Cisplatin or carboplatin DRUG

Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Jianhua Chang, MD,PhD

  Fudan University affiliated cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua chang, MD,PHD

CONTACT

13916619284; changjianhua@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: September 1, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Last Updated: September 3, 2010

Record last verified: 2010-09

Locations

CN (1)