Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
|Malignant Pleural Mesothelioma||Drug: Prolonged 6-hr infusion of gemcitabine||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma|
- Response rate [ Time Frame: Computerized tomography (CT) measurement of disease will be performed after 2nd cycle of chemotherapy and at the end of the 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
- Safety and tolerability [ Time Frame: During the study ]Safety and tolerability will be assessed by monitoring the adverse events during treatment and follow-up phase and graded according the NCI Common Toxicity Criteria (CTC), version 2.0. Participants will be followed until death or 2 to 7 years (average 4.5 years).
|Study Start Date:||December 2002|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Drug: Prolonged 6-hr infusion of gemcitabine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243632
|Institute of Oncology Ljubljana|
|Ljubljana, Slovenia, 1000|
|Study Director:||Matjaz Zwitter, MD, PhD||Institute of Oncology Ljubljana|