Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
NCT ID: NCT01769066
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
117 participants
INTERVENTIONAL
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1
Pemetrexed/Platinum
Interventions
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Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed/Platinum
Eligibility Criteria
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Inclusion Criteria
2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
3. Presence of at least one index lesion measurable by CT scan or MRI
4. Ecog0-1
5. Expected life time longer than 12 weeks
6. 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)
7. Signed written informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chang Jian Hua
Deputy director of department of medical oncology
Principal Investigators
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Chang jian hua, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer hospital Fudan University
Locations
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Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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Gefitinib-2009-cjh
Identifier Type: -
Identifier Source: org_study_id
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