Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Malignant Pleural Mesothelioma Clinical Trial

Official title:

A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243632
• Other study ID #: 86/12/02
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2010
• Last updated: November 17, 2010
• Start date: December 2002
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: Institute of Oncology Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma

Intervention

Drug:
• Prolonged 6-hr infusion of gemcitabine
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

Locations

Country	Name	City	State
Slovenia	Institute of Oncology Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana	Ministry of Higher Education, Science and Technology, Solvenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	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	No
Secondary	Safety and tolerability	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).	During the study	Yes