Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT01192243 |
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was: Recruiting
First Posted : September 1, 2010
Last Update Posted : September 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Toxicity Non-small Cell Lung Cancer | Drug: Gefitinib Drug: Pemetrexed Drug: Cisplatin or carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small |
Study Start Date : | December 2009 |
Estimated Primary Completion Date : | December 2011 |

- 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
- response rate [ Time Frame: six weeks ]
- Number of Participants with Adverse Events [ Time Frame: six weeks ]according to NCI CTC V3.0
- Progression free survival [ Time Frame: six weeks ]
- quality of life [ Time Frame: six weeks ]according to FACT-LCS scores

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192243
Contact: Jianhua chang, MD,PHD | 13916619284 | changjianhua@hotmail.com |
China, Shanghai | |
Cancer hospital Fudan University | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Jianhua Chang, MD,PhD 13916619284 changjianhua@hotmail.com |
Principal Investigator: | Jianhua Chang, MD,PhD | Fudan University affiliated cancer hospital |
Responsible Party: | Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT01192243 |
Other Study ID Numbers: |
Iressa combined with Pem/Cis |
First Posted: | September 1, 2010 Key Record Dates |
Last Update Posted: | September 3, 2010 |
Last Verified: | September 2010 |
Objective response rate Time to Progression Quality of Live |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Cisplatin Carboplatin Pemetrexed Gefitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |