Patients with histologically or cytologically proven malignant mesothelioma MedDRA version: 21.0 Level: LLT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemcitabine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg milligram(s)
Concentration type: range
Conc
Sponsors
Stichting NVALT studies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically or cytologically proven malignant mesothelioma • Age >18 years. • At the date of randomisation, the patients must have completed 4 cycles of first-line chemotherapy with a platinum (cisplatin or carboplatin) and pemetrexed combination at least 21 days but no more than 42 days prior to study entry, and have no evidence of progressive disease following first-line treatment. • Measurable or evaluable disease, according to modified RECIST criteria for pleural mesothelioma • Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures. • WHO performance status = 2 • Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry: - Hematology: Neutrophil count = 1.5 x 109/l, Platelets = 100 x 109/l, Hemoglobin = 6.2 mmol/l. - Hepatic function as defined by serum bilirubin = 1.25 times the upper limit of normal (ULN), ALT and AST = 2.5 times the ULN, except if liver metastases then ALAT and ASAT =65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: • Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency. • Presence of symptomatic CNS metastases. • Radiotherapy within 2 weeks prior to study entry. • Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition. • Concomitant administration of any other experimental drugs under investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the potential improvement of the duration of progression-free survival by maintenance treatment with gemcitabine;Secondary Objective: 1. To compare the objective radiological response (ORR) rate 2. To compare overall survival (OS) 3. To assess and compare the lung function 4. To describe the toxicity 5. To identify potential biomarkers ;Primary end point(s): The primary endpoint is progression free survival, defined as time from randomisation to disease progression or death (in case no progression has been documented);Timepoint(s) of evaluation of this end point: every 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events - Objective radiological response rate in patients with measurable disease - Overall survival - Changes in vital capacity and FEV1. ;Timepoint(s) of evaluation of this end point: every 6 weeks until off-study, thereafter every 12 weeks until dead | — |
Countries
Netherlands
Contacts
Public ContactNVALT Datacenter
NVALT
Outcome results
None listed