A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma
The purpose of this study is to evaluate new regimen of treatment for its activity in
malignant pleural mesothelioma (MPM). The primary objectives of the trial are assessing the
treatment toxicity, response rate, and progress free survival; secondary objectives are
assessment of overall survival and quality of life.
- Biopsy-proven diagnosis of MPM
- Inoperable for anatomic or physiological reason
- Measurable and previously unirradiated lesion
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
- Adequate haematopoietic, liver, and kidney function.
- Signed informed consent for participation in the trial
- Significant medical co-morbidity
- Pregnant or lactating women
- History of the cancer in the previous 10 years or breast cancer ever.
The general treatment schedule will be identical for all patients: gemcitabine in 6-hours
infusion on days 1 and 8, and cisplatin at 75 mg/m2 on day 2 of a 3-weekly cycle with
standard antiemetic treatment using metoclopramide, dexamethasone, aprepitant, and
granisetron. After 4 cycles, patients not in progression and without serious toxicity
continued with additional 2 cycles of monotherapy with gemcitabine in prolonged infusion.
National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0 will be used for
grading the toxicity. In the day of administration of the cytotoxic drug complete blood cell
count and chemistry panel will be performed, and the treatment will be reduced or avoided in
the event of bone marrow suppression or decline in renal clearance. In cases of Grade I (NCI
CTC, vs. 2.0) neutropenia and/or thrombocytopenia, the dose of gemcitabine will be reduced
to 75%; the drug will be omitted with Grade II or greater neutro/thrombocytopenia. Cisplatin
will be omitted in cases of Grade ≥ II nephrotoxicity and/or grade III nausea or vomiting.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of the treatment will be measured by response rate (RR) and disease control rate (DCR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for assessment of response in malignant pleural mesothelioma
Computerized tomography (CT) measurement of disease will be performed after 2nd cycle of chemotherapy and at the end of the treatment
Matjaz Zwitter, MD, PhD
Institute of Oncology Ljubljana
Slovenia: Ethics Committee