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Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Brief Summary

To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.

Tracking Information
First Received DateNovember 8, 2005
Last Changed DateNovember 5, 2007
Start DateOctober 2005
Primary Outcome Measures

To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate

Secondary Outcome Measures

Duration of response

Progression free survival

Median survival time

1 year survival rate

Pulmonary function

QOL

Safety

Plasma concentration

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesotherioma
Intervention
  • Drug: Pemetrexed
  • Drug: Cisplatin
Recruitment Information
Recruitment StatusCompleted
Enrollment12
GenderAll
Ages20 Years - 75 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

- Inapplicable for radical operation

- Not received prior systemic chemotherapy

- Performance status: 0-1

Exclusion Criteria:

- Having a history of sensitivity to platinum agent, folic acid or vitamin B12

Administrative Information
NCTIDNCT00251550
SponsorEli Lilly and Company
Verification DateNovember 2007
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

Yes   No

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