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Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

NCT01243632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2010-11-18

No results posted yet for this study

Summary

Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DRUG

Prolonged 6-hr infusion of gemcitabine

Gemcitabine 250 mg/m2 in prolonged 6 hr infusion on day 1 and 8, and cisplatin at 75 mg/m2 on day 2 of 3 week cycle, for 4-6 cycles

Sponsors & Collaborators

  • Ministry of Higher Education, Science and Technology, Solvenia

    collaborator OTHER_GOV

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Matjaz Zwitter, MD, PhD · Institute of Oncology Ljubljana

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01243632 on ClinicalTrials.gov