Brief Title
Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
Official Title
A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Safety and tolerability
Condition
Malignant Pleural Mesothelioma
Intervention
Prolonged 6-hr infusion of gemcitabine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
78
Start Date
December 2002
Completion Date
June 2010
Primary Completion Date
June 2010
Eligibility Criteria
Inclusion Criteria:
- Biopsy-proven diagnosis of malignant pleural mesothelioma
- 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.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Matjaz Zwitter, MD, PhD, ,
Location Countries
Slovenia
Location Countries
Slovenia
Administrative Informations
NCT ID
NCT01243632
Organization ID
86/12/02
Study Sponsor
Institute of Oncology Ljubljana
Collaborators
Ministry of Higher Education, Science and Technology, Solvenia
Study Sponsor
Matjaz Zwitter, MD, PhD, Study Director, Institute of Oncology Ljubljana
Verification Date
November 2010