Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Fudan University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192243
First Posted: September 1, 2010
Last Update Posted: September 3, 2010
Information provided by:
Fudan University
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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 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Fudan University:
Primary Outcome Measures:
- response rate [ Time Frame: six weeks ]
Secondary Outcome Measures:
- 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
| 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
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
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
| 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 |
| First Submitted: | August 4, 2010 |
| First Posted: | September 1, 2010 |
| Last Update Posted: | September 3, 2010 |
| Last Verified: | September 2010 |
Keywords provided by Fudan University:
|
Objective response rate Time to Progression Quality of Live |
Additional relevant MeSH terms:
|
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 |
Gefitinib Cisplatin Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |