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Trial Title:
Vinorelbine-ifosfamide Versus Gefitinib for EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients
NCT ID:
NCT01749072
Condition:
Non-small Cell Lung Cancer
Effects of Chemotherapy
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Vinorelbine
Ifosfamide
Gefitinib
Conditions: Keywords:
non small cell lung cancer
chemotherapy
gefitinib
vinorelbine
ifosfamide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gefitinib group
Description:
Gefitinib 250mg once per day until the progression disease or intolerant side effects
Arm group label:
Gefitinib
Other name:
Gefitinib (Iressa)
Intervention type:
Drug
Intervention name:
Vinorelbine, Ifosfamide, Mesna
Description:
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;
Arm group label:
Vinorelbine-Ifosfamide
Other name:
VI group
Summary:
In the National Comprehensive Cancer Network (NCCN) guideline for NSCLC, epidermal growth
factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is recommended as the third-line
treatment for EGFR gene mutation negative NSCLC patients who failed to the first-line
platinum doublet chemotherapy [i.e. paclitaxel-carboplatin (PC) or gemcitabine-cisplatin
(GP)] and the second-line chemotherapy with docetaxel or pemetrexed. But as we know, if
patients had no EGFR gene mutation, EGFR-TKI treatment is not effective. The overall
survival is short and the objective response rate is low. As for EGFR gene wild type
patients with good performance status, besides EGFR-TKI treatment, other first generation
cytotoxic drugs i.e. vinorelbine or ifosfamide maybe an alternative treatment. So the
purpose of this clinical trial is to compare the effectiveness and safety of
vinorelbine-ifosfamide with gefitinib in advanced or metastatic EGFR gene mutation
negative NSCLC patients.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age range:18-70 years old
- life expectancy more than 12 weeks
- histologically or cytologically confirmed inoperable NSCLC (stage ⅢB/Ⅳ)
- ineligible for curative radiotherapy
- no prior radiotherapy for the target lesions
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;
- prior treatments include first-line platinum doublet chemotherapy i.e. PC or GP and
second-line chemotherapy with docetaxel or pemetrexed;
- No EGFR gene mutation detected by Scorpions-ARMS;
- at least one bidimensionally measurable or radiographically assessable lesion;
- adequate bone marrow reserve;
- adequate hepatic and renal function;
Exclusion Criteria:
- prior treatments including any of the following drugs:gefitinib,vinorelbine and
ifosfamide;
- additional malignancies;
- uncontrolled systemic disease;
- any evidence of clinically active interstitial lung disease;
- newly diagnosed central nervous system (CNS) metastasis and not treated by
radiotherapy or surgery;
- pregnancy or breast feeding phase;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Respiratory Medicine, Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Mengzhao Wang, MD
Phone:
010-69155039
Phone ext:
+86
Email:
mengzhaowang@sina.com
Contact backup:
Last name:
Jing Zhao, MD
Phone:
010-69158206
Phone ext:
+86
Email:
pumchzj@sina.com
Investigator:
Last name:
Wei Zhong, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jinmei Luo, MD
Email:
Sub-Investigator
Start date:
December 2012
Completion date:
December 2017
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01749072