Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

NCT01243632 | Completed Phase 2

• 1 other identifier: 86/12/02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Mesothelioma

Keywords

malignant pleural mesothelioma; chemotherapy; gemcitabine; cisplatin; long infusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and tolerability

  During the study

Interventions

Prolonged 6-hr infusion of gemcitabine DRUG

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant medical co-morbidity
• Pregnant or lactating women
• History of the cancer in the previous 10 years or breast cancer ever.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• Ministry of Higher Education, Science and Technology, Solvenia: collaborator

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matjaz Zwitter, MD, PhD

  Institute of Oncology Ljubljana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 18, 2010
• Study Start: December 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

SL (1)