Vinorelbine-ifosfamide Versus Gefitinib for EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients
|ClinicalTrials.gov Identifier: NCT01749072|
Recruitment Status : Unknown
Verified December 2012 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : December 13, 2012
Last Update Posted : December 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Effects of Chemotherapy||Drug: Gefitinib group Drug: Vinorelbine, Ifosfamide, Mesna||Phase 2|
Ifosfamide is a first generation cytotoxic drug to treat NSCLC. Phase Ⅱ studies demonstrated that single-agent ifosfamide administrated by various schedules produces response rates of 15-29%, with media survival times of 5-7 months. Ifosfamide has also been used in various combination regimens to treat NSCLC, including platinum based and non-platinum regimens. But in refractory NSCLC patients platinum and some third generation cytotoxic drugs have been used before. So in this study, ifosfamide is combined with vinorelbine. In previous study, Masters reported the objective response rate was 40% and the median survival duration was 50 weeks, with a 1-year survival rate of 48% with vinorelbine-ifosfamide regimen [Vinorelbine 15 mg/m2 on days 1-3, and ifosfamide 2.0g/m2 on days 1-3 with granulocyte-colony stimulating factor (G-CSF) support]. The dose limiting toxicity (DLT) of this regimen is myelosuppression. In our experience, the regimen of vinorelbine 25mg/m2 d1, d8 and ifosfamide 1.25g/m2 d1-d3 with Mesna uroprotection is safe in Chinese population and the objective response rate is about 7% (data not published).
Gefitinib is the first small molecule inhibitor that has directed activity towards EGFR and has shown appreciable response rates in phase Ⅱ trials of patients with previously treated advanced NSCLC. In the posterior analysis of Iressa Dose Evaluation in Advanced Lung Cancer (IDEAL) and IRESSA Survival Evaluation in Lung Cancer (ISEL) trials, the response rate with gefitinib ranges from 2.6% to 10% in wild-type EGFR gene NSCLC patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅱ Randomized Clinical Trial Comparing Vinorelbine-ifosfamide With Gefitinib as Third-line Treatment in Advanced EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Gefitinib group Gefitinib (Iressa) 250mg once per day until progression disease or intolerant side effects
Drug: Gefitinib group
Gefitinib 250mg once per day until the progression disease or intolerant side effects
Other Name: Gefitinib (Iressa)
VI group Vinorelbine 25mg/m2 d1,d8;Ifosfamide 1.25g/m2 d1-d3(Usually Ifosfamide 2g d1-d3 with Mesna 400mg 0,4,8hours after Ifosfamide administration for 3 days);every 3 weeks;at least for 2-6 cycles depending on the progression disease or the patient's physical condition
Drug: Vinorelbine, Ifosfamide, Mesna
Vinorelbine 25mg/m2 d1,d8; Ifosfamide 1.25g/m1 d1-d3 (Usually 2g d1-d3); Mesna 400mg 0,4,8 hours after Ifosfamide administration for uroprotection d1-d3;
Other Name: VI group
- Progression free survival [ Time Frame: up to 52 weeks (about one year) ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
- Overall survival [ Time Frame: Up to 100 weeks ]From date of randomization until the date of death from any cause, assessed up to 100 weeks.
- objective response rate [ Time Frame: up to 9 weeks ]The objective response rate includes the complete remission and partial remission rate.
- the score of functional assessment of cancer treatment-lung (FACT-L) [ Time Frame: Up to 100 weeks ]FACL-L is assessed at different time points.(Date of randomization, 1 week after chemotherapy/EGFR-TKI, every cycle of chemotherapy/EGFR-TKI, every month of EGFR-TKI treatment/observation, up to 100 weeks)
- Number of participants with adverse events [ Time Frame: Up to six months ]The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria (Version 3.0) (NCI-CTC).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749072
|Contact: Mengzhao Wang, MD||010-69155039 ext +firstname.lastname@example.org|
|Contact: Jing Zhao, MD||010-69158206 ext +email@example.com|
|Department of Respiratory Medicine, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Mengzhao Wang, MD 010-69155039 ext +86 firstname.lastname@example.org|
|Contact: Jing Zhao, MD 010-69158206 ext +86 email@example.com|
|Sub-Investigator: Wei Zhong, MD|
|Sub-Investigator: Jinmei Luo, MD|
|Principal Investigator:||Mengzhao Wang, MD||Department of Respiratory Medicine, Peking Unoin Medical College Hospital|