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Trial Title:
Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma
NCT ID:
NCT01281800
Condition:
Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Gemcitabine in long infusion
Description:
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.
Arm group label:
Cisplatin with gemcitabine in long infusion
Arm group label:
Cisplatin with pemetrexed
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.
Detailed description:
Combination of pemetrexed and cisplatin is now considered the standard systemic treatment
for mesothelioma. Three arguments against such a position are: 1. Pemetrexed in
combination with cisplatin was registered for mesothelioma on the basis of superiority
over cisplatin alone, a clearly suboptimal control arm; 2. Several Phase II trials of
gemcitabine in standard doses or as low-dose in long infusion in combination with
cisplatin have shown at least comparable activity; 3. Due to high cost, pemetrexed is not
available to many patients in countries with limited health care resources. During the
past five years, our research team in Ljubljana conducted a Phase II trial of low-dose
gemcitabine (250 mg/m2) in 6-hours infusion and cisplatin for patients with mesothelioma.
In an unselected population of patients including those in poor performance status,
elderly, patients with advanced extrathoracic disease and patients in progression after
previous chemotherapy, the response rate was 54%, and median survival was 16.5 months. On
the basis of this favourable experience and in search of cost-effective treatment for
mesothelioma, we here propose a randomised Phase II clinical trial to compare efficacy
and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine
in long infusion. The primary endpoints are response rate and time to progression;
secondary endpoints are survival, toxicity and quality of life.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histologically proven mesothelioma. While local histopathology exam is sufficient to
register a patient for the trial, all biopsies will be subject to central review
(please see Section 5.3.)
- no history of other malignancy; or in complete remission for > 3 years if previously
treated for other malignancy;
- chemo-naive;
- performance status ≥ 70% (Karnofsky); or ECOG 0 - 2 ;
- no peripheral neuropathy grade 2 or more (common toxicity criteria - CTC, NCI),
unless mechanical in origin;
- no vascular disease grade 2 or more (NCI CTC ver.3);
- hemoglobin > 100 g/L;
- neutrophils > 2.0 g/L;
- platelets > 100 x 109 /L;
- kidney function: creatinine within normal limits + ECC > 60 mL/min; or ECC > 100
mL/min;
- liver function: bilirubin < 1.25 x UNL; AST/ALT < 2 x UNL;
- cardiac compensation;
- no active infection or other serious concomitant disease;
- women are not pregnant
- patient's understanding of the disease and treatment and written informed consent.
Exclusion Criteria:
• significant medical co-morbidity
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Oncology Ljubljana
Address:
City:
Ljubljana
Zip:
1000
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Viljem Kovac, MD
Phone:
+386 1 5879 504
Email:
vkovac@onko-i.si
Investigator:
Last name:
Matjaz Zwitter, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Viljem Kovac, MD
Email:
Principal Investigator
Start date:
August 2008
Lead sponsor:
Agency:
Institute of Oncology Ljubljana
Agency class:
Other
Collaborator:
Agency:
Slovenian Research Agency
Agency class:
Other
Source:
Institute of Oncology Ljubljana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01281800
