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ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

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ClinicalTrials.gov Identifier: NCT01810367
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University

Study Description
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Brief Summary:
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: ABX Combined With Cisplatin Drug: Gemcitabine Combined With Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ABX Combined With Cisplatin
ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt
 Drug: ABX Combined With Cisplatin
Active Comparator: Gemcitabine Combined With Cisplatin
gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
 Drug: Gemcitabine Combined With Cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

1.18~75 years 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 have 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
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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): NCT01810367


Locations
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China, Shanghai
Cancer hospital Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Chang Jian Hua, Vice director of department of chemotherapy, Fudan University
ClinicalTrials.gov Identifier: NCT01810367     History of Changes
Other Study ID Numbers: ABX-CJH
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Chang Jian Hua, Fudan University:
PFS
Additional relevant MeSH terms:
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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
Gemcitabine
 Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs