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Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

NCT ID: NCT01243632

Last Updated: 2010-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Malignant Pleural Mesothelioma

Keywords

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malignant pleural mesothelioma chemotherapy gemcitabine cisplatin long infusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Higher Education, Science and Technology, Solvenia

OTHER_GOV

Sponsor Role collaborator

Institute of Oncology Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Institute of Oncology Ljubljana

Principal Investigators

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Matjaz Zwitter, MD, PhD

Role: STUDY_DIRECTOR

Institute of Oncology Ljubljana

Locations

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Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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86/12/02

Identifier Type: -

Identifier Source: org_study_id