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Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma

NCT01281800 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-01-24

No results posted yet for this study

Summary

This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.

Conditions

Interventions

PROCEDURE

Gemcitabine in long infusion

TREATMENT A: Day 1: Pemetrexed 500 mg/m2 Cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: folic acid \[Tifol 400 mg tbl (350-1000 mg), beginning 7 days before CT, every day, till 3 week after the KT\], vitamin B-12 \[OH-B12 i.m., beginning in 7 days before CT, than at 3. + 6. cycles of KT + 9. week after the KT\], corticosteroids, hydration, antiemetic, LMW heparin as thromboprophylaxis. In the absence of progression, 4 cycles of chemotherapy with pemetrexed and cisplatin will be given, followed by two additional cycles of pemetrexed as monotherapy. TREATMENT B: Days 1 and 8: gemcitabine 250 mg/m2 in 6 hours day 2: cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: corticosteroids, hydration, antiemetics, LMW heparin as thromboprophylaxis. In the absence of progression, 4 cycles of chemotherapy with gemcitabine and cisplatin will be given, followed by two additional cycles of gemcitabine alone as monotherapy.

Sponsors & Collaborators

  • Slovenian Research Agency

    collaborator OTHER

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Viljem Kovac, MD · Institute of Oncology Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2014-08-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01281800 on ClinicalTrials.gov