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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

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