Status:

UNKNOWN

A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

Lead Sponsor:

Fudan University

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

70+ years

Phase:

NA

Brief Summary

PFS

Eligibility Criteria

Inclusion

  • .≥65 years or PS 2
  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
  • Presence of at least one index lesion measurable by CT scan or MRI
  • leucocyte ≥ 3.5×109/L
  • neutrophil ≥ 1.5×109/L
  • platelet ≥ 80×109/L
  • Hemoglobin ≥ 9g/L
  • ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
  • BUN≤ 1.5×ULN
  • Signed written informed consent

Exclusion

  • squamous carcinoma or small cell lung cancer
  • Patients were allergic to pemetrexed
  • Patients received chemotherapy before
  • Uncontrolled acute infection
  • .Uncontrolled pleural effusion
  • Severe symptomatic heart disease
  • 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
  • Mental disorientation of disorder
  • Glucocorticoids taboo

Key Trial Info

Start Date :

February 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT01860508

Start Date

February 1 2013

Last Update

July 8 2013

Active Locations (1)

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1

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China, 200032