Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 2

Summary: 
      Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in
      mesothelioma patients. However, median survival of this patient group was only about 12
      months. With intent to find more effective treatment the investigators performed phase II
      study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in
      combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer
      Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore
      such regiment in patients with malignant pleural mesothelioma (MPM) as well.
    

Detailed description: 
      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.

      Inclusion criteria:

        -  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

      Exclusion criteria:

        -  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.
    

Intervention name(s): Prolonged 6-hr infusion of gemcitabine
Intervention type(s): Drug
Intervention description(s): Gemcitabine 250 mg/m2 in prolonged 6 hr infusion on day 1 and 8, and cisplatin at 75 mg/m2 on day 2 of 3 week cycle, for 4-6 cycles
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malignant pleural mesothelioma; chemotherapy; gemcitabine; cisplatin; long infusion